search
Back to results

Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)

Primary Purpose

Emphysema

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Lung Volume Reduction Coil (LVRC) (PneumRx)
Control
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema focused on measuring Emphysema, RePneu

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient greater than or equal to 35 years of age
  • High resolution CT scan indicates unilateral or bilateral emphysema
  • High resolution CT scan indicates homogeneous or heterogeneous emphysema
  • Patient has post-bronchodilator FEV1 less than or equal to 45% predicted
  • Total Lung Capacity greater than 100% predicted
  • Patient has marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4
  • Patient has stopped smoking for a minimum of 8 weeks prior to entering the study
  • Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form

Exclusion Criteria:

  • Patient has a change in FEV1 greater than 20% post-bronchodilator
  • Patients DLCO less than 20% predicted
  • Patient has a history of recurrent clinically significant respiratory infection
  • Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram
  • Patient has an inability to walk greater than 140 meters (150 yards) in 6 minutes
  • Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
  • Patient is pregnant or lactating
  • Patient has an inability to tolerate bronchoscopy under heavy sedation or anesthesia
  • Patient has clinically significant bronchiectasis
  • Patient has giant bullae greater than 1/3 lung volume
  • Patient has had previous LVR surgery, lung transplant or lobectomy
  • Patient has been involved in other pulmonary drug studies with 30 days prior to this study
  • Patient is taking greater than 20 mg prednisone (or similar steroid) daily
  • Patient is on Plavix or has not been weaned off prior to procedure
  • Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Sites / Locations

  • Chelsea and Westminster Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lung Volume Reduction Coil (LVRC)

Control

Arm Description

Lung Volume Reduction Coil (LVRC)

Standard of Care

Outcomes

Primary Outcome Measures

St. George's Respiratory Questionnaire (SGRQ)
The primary efficacy endpoint will be the difference between treatment and control groups in the change in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) to the three month Follow-Up Visit.

Secondary Outcome Measures

Full Information

First Posted
April 1, 2011
Last Updated
July 15, 2021
Sponsor
Boston Scientific Corporation
Collaborators
PneumRx, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01334307
Brief Title
Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)
Official Title
Randomized Controlled Trial Of RePneu (LVRC) Endobronchial Coils For The Treatment Of Severe Emphysema With Hyperinflation (RESET Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
Collaborators
PneumRx, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema
Keywords
Emphysema, RePneu

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lung Volume Reduction Coil (LVRC)
Arm Type
Experimental
Arm Description
Lung Volume Reduction Coil (LVRC)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Standard of Care
Intervention Type
Device
Intervention Name(s)
Lung Volume Reduction Coil (LVRC) (PneumRx)
Other Intervention Name(s)
LVRD
Intervention Description
Lung Volume Reduction Coil (LVRC)
Intervention Type
Device
Intervention Name(s)
Control
Other Intervention Name(s)
LVRC Control treatment is Standard of Care
Intervention Description
Standard of Care
Primary Outcome Measure Information:
Title
St. George's Respiratory Questionnaire (SGRQ)
Description
The primary efficacy endpoint will be the difference between treatment and control groups in the change in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) to the three month Follow-Up Visit.
Time Frame
three month Follow-Up Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient greater than or equal to 35 years of age High resolution CT scan indicates unilateral or bilateral emphysema High resolution CT scan indicates homogeneous or heterogeneous emphysema Patient has post-bronchodilator FEV1 less than or equal to 45% predicted Total Lung Capacity greater than 100% predicted Patient has marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4 Patient has stopped smoking for a minimum of 8 weeks prior to entering the study Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form Exclusion Criteria: Patient has a change in FEV1 greater than 20% post-bronchodilator Patients DLCO less than 20% predicted Patient has a history of recurrent clinically significant respiratory infection Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram Patient has an inability to walk greater than 140 meters (150 yards) in 6 minutes Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Patient is pregnant or lactating Patient has an inability to tolerate bronchoscopy under heavy sedation or anesthesia Patient has clinically significant bronchiectasis Patient has giant bullae greater than 1/3 lung volume Patient has had previous LVR surgery, lung transplant or lobectomy Patient has been involved in other pulmonary drug studies with 30 days prior to this study Patient is taking greater than 20 mg prednisone (or similar steroid) daily Patient is on Plavix or has not been weaned off prior to procedure Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pallav Shah, MD
Organizational Affiliation
Chelsea and Westminster Hospital
Official's Role
Principal Investigator
Facility Information:
City
Glasgow
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital
City
London
Country
United Kingdom
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25853697
Citation
Zoumot Z, Kemp SV, Singh S, Bicknell SR, McNulty WH, Hopkinson NS, Ross ET, Shah PL. Endobronchial coils for severe emphysema are effective up to 12 months following treatment: medium term and cross-over results from a randomised controlled trial. PLoS One. 2015 Apr 8;10(4):e0122656. doi: 10.1371/journal.pone.0122656. eCollection 2015.
Results Reference
derived
PubMed Identifier
24429129
Citation
Shah PL, Zoumot Z, Singh S, Bicknell SR, Ross ET, Quiring J, Hopkinson NS, Kemp SV; RESET trial Study Group. Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial. Lancet Respir Med. 2013 May;1(3):233-40. doi: 10.1016/S2213-2600(13)70047-X. Epub 2013 Apr 23.
Results Reference
derived

Learn more about this trial

Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)

We'll reach out to this number within 24 hrs