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RADIANCE Continued Access Protocol (RADIANCE CAP)

Primary Purpose

Hypertension, Hypertension, Resistant to Conventional Therapy, Vascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Renal Denervation
Sponsored by
ReCor Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Blood Pressure, Uncontrolled Hypertension, Essential Hypertension, Resistant Hypertension, Denervation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Average office BP ≥140/90 mmHg at screening visit despite taking stables doses of antihypertensive medications for at least 4 weeks prior to consent
  • Documented daytime ABP ≥135/85 mmHg following 4 week run-in/standardization period on antihypertensive medication regimen

Exclusion Criteria:

  • Renal artery anatomy ineligible for treatment
  • Secondary hypertension not including sleep apnea
  • Type I diabetes mellitus or uncontrolled Type II diabetes (defined as plasma HbA1c ≥9.0%)
  • eGFR <40
  • Brachial circumference ≥42 cm
  • Any history of cerebrovascular event or severe cardiovascular event within 3 months prior to consent
  • Documented repeat (>1) hospitalization for hypertensive crisis within 3 months prior to consent
  • Documented confirmed episode(s) of unstable angina within 3 months prior to consent
  • Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
  • Primary pulmonary hypertension
  • Night shift workers
  • Pregnant, nursing or planning to become pregnant

Sites / Locations

  • Cardiovascular Institute of San DiegoRecruiting
  • Cedars-Sinai Medical CenterRecruiting
  • Sutter HealthRecruiting
  • Pacific Heart InstituteRecruiting
  • Bridgeport HospitalRecruiting
  • The Cardiac and Vascular InstituteRecruiting
  • Baptist Hospital of MiamiRecruiting
  • Orlando HealthRecruiting
  • EmoryRecruiting
  • Northwestern UniversityRecruiting
  • Prairie Education and Research CooperativeRecruiting
  • SIU MedicineRecruiting
  • Parkview Research CenterRecruiting
  • UnityPoint Health-Des MoinesRecruiting
  • Ochsner Medical CenterRecruiting
  • Lifebridge HealthRecruiting
  • Tidal HealthRecruiting
  • Boston Medical CenterRecruiting
  • The Brigham and Women's HospitalRecruiting
  • Henry Ford HospitalRecruiting
  • Saint Luke's HospitalRecruiting
  • Renown Regional Medical CenterRecruiting
  • Cardiovascular Associates of the Delaware ValleyRecruiting
  • NJ Heart & VascularRecruiting
  • Columbia University Medical Center/NYPHRecruiting
  • Stony Brook University HospitalRecruiting
  • University of North CarolinaRecruiting
  • Cone HealthRecruiting
  • St. Francis HospitalRecruiting
  • Penn MedicineRecruiting
  • UPMC Heart and Vascular CenterRecruiting
  • Medical University of South CarolinaRecruiting
  • The University of Texas Health Sciences Center at HoustonRecruiting
  • Texas Tech University Health Sciences CenterRecruiting
  • University of Texas Health Sciences Center, San AntonioRecruiting
  • Baylor Scott & White Research InstituteRecruiting
  • Swedish Health ServicesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal Denervation

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Adverse Events
Change in average daytime ambulatory systolic BP

Secondary Outcome Measures

Change in average 24-hr/night-time ambulatory systolic BP
Change in average daytime/24-hr/night-time ambulatory systolic BP
Change in average office systolic/diastolic BP
Change in average home systolic/diastolic BP
Change in average 24-hr/night-time ambulatory diastolic BP

Full Information

First Posted
August 17, 2021
Last Updated
August 2, 2023
Sponsor
ReCor Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05017935
Brief Title
RADIANCE Continued Access Protocol
Acronym
RADIANCE CAP
Official Title
RADIANCE Continued Access Protocol (RADIANCE CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ReCor Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hypertension, Resistant to Conventional Therapy, Vascular Diseases, Cardiovascular Diseases
Keywords
Blood Pressure, Uncontrolled Hypertension, Essential Hypertension, Resistant Hypertension, Denervation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Renal Denervation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Renal Denervation
Intervention Description
Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System)
Primary Outcome Measure Information:
Title
Incidence of Adverse Events
Time Frame
From baseline to 60 months
Title
Change in average daytime ambulatory systolic BP
Time Frame
From baseline to 2 months post procedure
Secondary Outcome Measure Information:
Title
Change in average 24-hr/night-time ambulatory systolic BP
Time Frame
From baseline to 2 months post procedure
Title
Change in average daytime/24-hr/night-time ambulatory systolic BP
Time Frame
From Baseline to Months 6 and 12 post procedure
Title
Change in average office systolic/diastolic BP
Time Frame
From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure
Title
Change in average home systolic/diastolic BP
Time Frame
From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure
Title
Change in average 24-hr/night-time ambulatory diastolic BP
Time Frame
From baseline to Months 2, 6, and 12 post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Average office BP ≥140/90 mmHg at screening visit despite taking stables doses of antihypertensive medications for at least 4 weeks prior to consent Documented daytime ABP ≥135/85 mmHg following 4 week run-in/standardization period on antihypertensive medication regimen Exclusion Criteria: Renal artery anatomy ineligible for treatment Secondary hypertension not including sleep apnea Type I diabetes mellitus or uncontrolled Type II diabetes (defined as plasma HbA1c ≥9.0%) eGFR <40 Brachial circumference ≥42 cm Any history of cerebrovascular event or severe cardiovascular event within 3 months prior to consent Documented repeat (>1) hospitalization for hypertensive crisis within 3 months prior to consent Documented confirmed episode(s) of unstable angina within 3 months prior to consent Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea Primary pulmonary hypertension Night shift workers Pregnant, nursing or planning to become pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helen Reeve-Stoffer, PhD
Phone
+44 7947 748006
Email
hreeve-stoffer@recormedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Sheehan, MLIS
Email
liz.sheehan@recormedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Fisher, MD
Organizational Affiliation
Brigham and Women's Hospital/Harvard Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ajay Kirtane, MD, SM
Organizational Affiliation
Columbia University Medical Center/NYPH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Institute of San Diego
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Lawrence
Email
janet.lawrence@cvisd.com
First Name & Middle Initial & Last Name & Degree
Mehran Moussavian, DO
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Tran
Email
anne.tran@cshs.org
First Name & Middle Initial & Last Name & Degree
Florian Rader, MD
Facility Name
Sutter Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammy Donnel
Email
tammy.donnel@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
Powell Jose, MD
Facility Name
Pacific Heart Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorothy Peng
Email
dorothy.peng@providence.org
First Name & Middle Initial & Last Name & Degree
Shephal Doshi, MD
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica LeBlanc
Email
jessica.leblanc@bpthosp.org
First Name & Middle Initial & Last Name & Degree
Edward Tuohy, MD
Facility Name
The Cardiac and Vascular Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marti Roberson
Phone
352-375-1212
Email
mroberson@TCAVI.com
First Name & Middle Initial & Last Name & Degree
Christopher Caputo, MD
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margie McKercher
Email
vgarabed@baptisthealth.net
First Name & Middle Initial & Last Name & Degree
Ian Del Conde-Pozzi, MD
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Ngo
Email
george.ngo@orlandohealth.com
First Name & Middle Initial & Last Name & Degree
Farhan J Khawaja, MD
Facility Name
Emory
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Fiebach
Phone
404-686-6468
Email
amanda.fiebach@emoryhealthcare.org
First Name & Middle Initial & Last Name & Degree
Chandanreddy Devireddy, MD
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamorabi Mkrdichian
Phone
312-926-2773
Email
hmkrdich@nm.org
First Name & Middle Initial & Last Name & Degree
Annalisa Romanenko
Phone
312-695-2928
Email
annalisa.romanenko@nm.org
First Name & Middle Initial & Last Name & Degree
Keith Benzuly, MD
Facility Name
Prairie Education and Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Bainter
Phone
217-492-9115
Email
lbainter@prairieresearch.com
First Name & Middle Initial & Last Name & Degree
Gabor Matos, MD
Facility Name
SIU Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9664
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Starkey
Phone
217-545-7616
Email
estarkey74@siumed.edu
First Name & Middle Initial & Last Name & Degree
John M. Flack, MD
Facility Name
Parkview Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mindi Zellers
Email
mindi.zellers@parkview.com
First Name & Middle Initial & Last Name & Degree
Roy Robertson, MD
Facility Name
UnityPoint Health-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Hahn
Email
kirstin.hahn@unitypoint.org
First Name & Middle Initial & Last Name & Degree
Lucas Groben, MD
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Harrison
Phone
504-703-5606
Email
michael.harrison@ochsner.org
First Name & Middle Initial & Last Name & Degree
James S. Jenkins, MD
Facility Name
Lifebridge Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Bliden
Phone
410-601-1412
Email
kbliden@lifebridgehealth.com
First Name & Middle Initial & Last Name & Degree
Paul Gurbel, MD
Facility Name
Tidal Health
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Brimer
Email
megan.brimer@tidalhealth.org
First Name & Middle Initial & Last Name & Degree
Steven Hearne, MD
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Artem Kaliaev
Email
artem.kaliaev@bmc.org
First Name & Middle Initial & Last Name & Degree
David Guez, MD
Facility Name
The Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Halliday
Phone
617-525-9725
Email
ihalliday@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Naomi Fisher, MD
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanee Schimmel, BSN, RN
Email
mschimm2@hfhs.org
First Name & Middle Initial & Last Name & Degree
Gerald Koenig, MD
Facility Name
Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana King
Phone
816-932-4948
Email
ddakon@saint-lukes.org
First Name & Middle Initial & Last Name & Degree
Steven B. Laster, MD
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa English
Email
lisa.english@renown.org
First Name & Middle Initial & Last Name & Degree
Michael Bloch, MD
Facility Name
Cardiovascular Associates of the Delaware Valley
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Siderio
Email
esiderio@hearthousenj.com
First Name & Middle Initial & Last Name & Degree
George Kaddissi, MD
Facility Name
NJ Heart & Vascular
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luot Lewis
First Name & Middle Initial & Last Name & Degree
Kintur Sanghvi, MD
Facility Name
Columbia University Medical Center/NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne M Edwards, Ph.D.
Phone
212-342-5128
Email
sme2146@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Ajay J Kirtane, MD
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8167
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth J Tenzler Stein
Email
ruth.stein@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
John P Reilly, MD
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Allen
Email
meghme@med.unc.edu
First Name & Middle Initial & Last Name & Degree
George R Stouffer, MD
Facility Name
Cone Health
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Knapp, RN
Email
jennifer.knapp@conehealth.com
First Name & Middle Initial & Last Name & Degree
Muhammad Arida, MD
Facility Name
St. Francis Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mani Cheruvu, PhD
Email
mcheruvu@saintfrancis.com
First Name & Middle Initial & Last Name & Degree
Sahil Agrawal, MD
Facility Name
Penn Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Didonato
Email
alexandra.didonato@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Debbie Cohen, MBBCH
Facility Name
UPMC Heart and Vascular Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Karan
Email
karang6@upmc.edu
First Name & Middle Initial & Last Name & Degree
John Pacella, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Awkar
Email
awkar@musc.edu
First Name & Middle Initial & Last Name & Degree
Thomas Todoran, MD
Facility Name
The University of Texas Health Sciences Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Menezes
Email
anna.m.menezes@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Konstantinos Charitakis, MD
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theresa Condez
Email
theresa.condez@ttuhsc.edu
First Name & Middle Initial & Last Name & Degree
Mohammad Ansari, MD
Facility Name
University of Texas Health Sciences Center, San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fazal Hussain, MD
Email
hussainf@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Anand Prassad, MD
Facility Name
Baylor Scott & White Research Institute
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margarite Grable
Email
margarite.grable@bswhealth.org
First Name & Middle Initial & Last Name & Degree
Timothy Mixon, MD
Facility Name
Swedish Health Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serena Risher
Phone
206-320-8283
Email
serena.risher@swedish.org
First Name & Middle Initial & Last Name & Degree
Paul P. Huang, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34010611
Citation
Azizi M, Sanghvi K, Saxena M, Gosse P, Reilly JP, Levy T, Rump LC, Persu A, Basile J, Bloch MJ, Daemen J, Lobo MD, Mahfoud F, Schmieder RE, Sharp ASP, Weber MA, Sapoval M, Fong P, Pathak A, Lantelme P, Hsi D, Bangalore S, Witkowski A, Weil J, Kably B, Barman NC, Reeve-Stoffer H, Coleman L, McClure CK, Kirtane AJ; RADIANCE-HTN investigators. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet. 2021 Jun 26;397(10293):2476-2486. doi: 10.1016/S0140-6736(21)00788-1. Epub 2021 May 16.
Results Reference
background
Links:
URL
https://www.recormedical.com/
Description
ReCor Medical company website
URL
https://www.highbptrial.com
Description
Study eligibility questionnaire; study summary and information

Learn more about this trial

RADIANCE Continued Access Protocol

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