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Safety and Effectiveness of Juveena™ Hydrogel System Following TCGP At High-Risk for Intrauterine Adhesions

Primary Purpose

Intrauterine Adhesion

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Juveena Hydrogel System
Sponsored by
Rejoni Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intrauterine Adhesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Premenopausal Candidate for one of the following hysteroscopic procedures: Adhesiolysis of moderate to severe adhesions confirmed hysteroscopically Hysteroscopic Myomectomy confirmed via imaging in subjects with symptomatic disease Subject agrees to all protocol requirements including returning for specified visits within intervals identified within this protocol. Subject is willing to undergo an SLH at the Week 8 visit. Subject agrees to abstain from sexual intercourse or use a reliable form of barrier contraception following the study procedure through the Week 8 visit. Subject has signed the IRB/EC approved informed consent Exclusion Criteria: Postmenopausal IUD present at time of TCGP (unless removed before or during procedure) Past history of endometrial cancer or atypical endometrial hyperplasia (endometrial intraepithelial neoplasia). Planned intrauterine interventions post-TCGP through the Week 8 visit. Recent intrauterine surgery within 6 weeks before the planned study procedure. Pregnant (positive pregnancy test) or lactating. Pregnancy within the last 6 weeks prior to the planned study procedure for a trimester loss (≤13 weeks gestation) within 3 months of planned study procedure for all other pregnancies. Active sexually transmitted infection (i.e., positive testing for gonorrhea/chlamydia), or genital or urinary tract infection at the time of procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis) or other active and/or systemic infection. Use of systemic corticosteroids within 1 week of study procedure. Treated with long-acting injectable hormone/hormone implant that would still be active at the time of the TCGP. Known allergy to FD&C No.1 dye or polyethylene glycol (PEG). Known clotting defects or bleeding disorders. Any other general health or mental condition that in the opinion of the investigator could represent an increased risk for the subject, affect the primary outcomes of this study and/or impact the subject's ability to comply with protocol requirements. Participating or considering participation in a clinical trial of another investigational drug or device during this study.

Sites / Locations

  • Arizona Gynecology ConsultantsRecruiting
  • UCSF Center for Reproductive HealthRecruiting
  • MedStar Washington Hospital CenterRecruiting
  • Dr. Charles Miller and AssociatesRecruiting
  • Cypress Medical Research CenterRecruiting
  • Newton Wellesley HospitalRecruiting
  • Boston IVFRecruiting
  • Maimonides Medical CenterRecruiting
  • Carolina Women's Research & Wellness CenterRecruiting
  • University Hospitals LanderbrookRecruiting
  • Seattle Reproductive Medicine
  • Generations Fertility CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transcervical Gynecological Procedure + Juveena Hydrogel

Transcervical Gynecological Procedure alone (standard of care)

Arm Description

Transcervical Gynecological Procedure + Juveena Hydrogel

Transcervical Gynecological Procedure alone (standard of care)

Outcomes

Primary Outcome Measures

Freedom from intrauterine adhesions (IUA)
Incidence of No IUA at second look hysteroscopy (SLH)

Secondary Outcome Measures

Severity of IUA
Severity of IUA classified according to March criteria at SLH
Freedom of IUA with superiority margin of 5% over control at IUA
Incidence of No IUA with superiority margin of 5% over control

Full Information

First Posted
May 24, 2022
Last Updated
September 26, 2023
Sponsor
Rejoni Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05394662
Brief Title
Safety and Effectiveness of Juveena™ Hydrogel System Following TCGP At High-Risk for Intrauterine Adhesions
Official Title
Safety and Effectiveness of Juveena™ Hydrogel System Following Transcervical Gynecologic Procedures (TCGP) At High-Risk for Intrauterine Adhesions: A Multicenter Randomized Controlled Subject and Evaluator Blinded Pivotal Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rejoni 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
This study is to determine whether intrauterine instillation of Juveena hydrogel following adhesiogenic hysteroscopic procedures (TCGP + Juveena) can safely and effectively reduce the incidence and severity of intrauterine adhesions (IUA) compared to TCGP alone.
Detailed Description
This is a prospective, multicenter, randomized controlled subject and evaluator-blinded pivotal study to investigate the safety and effectiveness of the Juveena Hydrogel System when used to reduce the occurrence of IUA in women undergoing TCGPs associated with a high prevalence of post-procedural IUA (i.e., adhesiolysis for moderate to severe adhesions or myomectomy of multiple or large myoma). A second look hysteroscopy (SLH) will be performed at the Week 8 visit to evaluate the presence and severity of IUA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Adhesion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Juveena Hydrogel vs No Hydrogel
Masking
ParticipantOutcomes Assessor
Masking Description
Subjects won't be told which group they were assigned. Primary outcome reviewed by blinded independent central review.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcervical Gynecological Procedure + Juveena Hydrogel
Arm Type
Experimental
Arm Description
Transcervical Gynecological Procedure + Juveena Hydrogel
Arm Title
Transcervical Gynecological Procedure alone (standard of care)
Arm Type
No Intervention
Arm Description
Transcervical Gynecological Procedure alone (standard of care)
Intervention Type
Device
Intervention Name(s)
Juveena Hydrogel System
Intervention Description
Application of a novel hydrogel immediately following the transcervical procedure
Primary Outcome Measure Information:
Title
Freedom from intrauterine adhesions (IUA)
Description
Incidence of No IUA at second look hysteroscopy (SLH)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Severity of IUA
Description
Severity of IUA classified according to March criteria at SLH
Time Frame
8 weeks
Title
Freedom of IUA with superiority margin of 5% over control at IUA
Description
Incidence of No IUA with superiority margin of 5% over control
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Premenopausal Candidate for one of the following hysteroscopic procedures: Adhesiolysis of moderate to severe adhesions confirmed hysteroscopically Hysteroscopic Myomectomy confirmed via imaging in subjects with symptomatic disease Subject agrees to all protocol requirements including returning for specified visits within intervals identified within this protocol. Subject is willing to undergo an SLH at the Week 8 visit. Subject agrees to abstain from sexual intercourse or use a reliable form of barrier contraception following the study procedure through the Week 8 visit. Subject has signed the IRB/EC approved informed consent Exclusion Criteria: Postmenopausal IUD present at time of TCGP (unless removed before or during procedure) Past history of endometrial cancer or atypical endometrial hyperplasia (endometrial intraepithelial neoplasia). Planned intrauterine interventions post-TCGP through the Week 8 visit. Recent intrauterine surgery within 6 weeks before the planned study procedure. Pregnant (positive pregnancy test) or lactating. Pregnancy within the last 6 weeks prior to the planned study procedure for a trimester loss (≤13 weeks gestation) within 3 months of planned study procedure for all other pregnancies. Active sexually transmitted infection (i.e., positive testing for gonorrhea/chlamydia), or genital or urinary tract infection at the time of procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis) or other active and/or systemic infection. Use of systemic corticosteroids within 1 week of study procedure. Treated with long-acting injectable hormone/hormone implant that would still be active at the time of the TCGP. Known allergy to FD&C No.1 dye or polyethylene glycol (PEG). Known clotting defects or bleeding disorders. Any other general health or mental condition that in the opinion of the investigator could represent an increased risk for the subject, affect the primary outcomes of this study and/or impact the subject's ability to comply with protocol requirements. Participating or considering participation in a clinical trial of another investigational drug or device during this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ian Feldberg
Phone
978-760-1742
Email
patientinfo@juveena.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Bissett
Phone
617-877-7599
Email
patientinfo@juveena.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Feldberg
Organizational Affiliation
Rejoni Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Gynecology Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KellyFNP Roy, MD
Email
kroy@azgyn.com
First Name & Middle Initial & Last Name & Degree
Kristina Calligan, FNP
Email
kcalligan@azgyn.com
Facility Name
UCSF Center for Reproductive Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Huddleston, MD
Email
Heather.Huddleston@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Jamie Corley
Email
Jamie.Corley@ucsf.edu
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Robinson, MD
First Name & Middle Initial & Last Name & Degree
Melissa Gonzales
Email
Melissa.K.Gonzales@medstar.net
Facility Name
Dr. Charles Miller and Associates
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Miller, MD
Email
chuckmiller@drcharlesmiller.com
First Name & Middle Initial & Last Name & Degree
Mary Johnston, BSN
Email
mjohnston@drcharlesmiller.com
Facility Name
Cypress Medical Research Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David A Grainger, MD
Email
dgrainger@cfrm.net
First Name & Middle Initial & Last Name & Degree
Wes Brown
Email
wbrown@cypressmrc.com
Facility Name
Newton Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Movilla, MD
Email
pmovilla@partners.org
First Name & Middle Initial & Last Name & Degree
Mollie O'Brien
Email
mobrien66@partners.org
Facility Name
Boston IVF
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pietro Bortoletto, MD
Email
pbortoletto@bostonivf.com
First Name & Middle Initial & Last Name & Degree
Kristen Rooney
Email
krooney@bostonivf.com
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Chudnoff, MD
Email
schudnoff@maimonidesmed.org
First Name & Middle Initial & Last Name & Degree
Olivia Sher
Email
osher@maimonidesmed.org
Facility Name
Carolina Women's Research & Wellness Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrea Lukes, MD
Email
andrealukes@cwrwc.com
First Name & Middle Initial & Last Name & Degree
Janet Davis
Email
janet@cwrwc.com
Facility Name
University Hospitals Landerbrook
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
41124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Flyckt, MD
Email
Rebecca.Flyckt2@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Bridget Ermlich
Email
Bridget.Ermlich@UHhospitals.org
Facility Name
Seattle Reproductive Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Withdrawn
Facility Name
Generations Fertility Care
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bala Bhagavath, MD
Email
bbhagavath@wisc.edu
First Name & Middle Initial & Last Name & Degree
Megan Waltz Peebles
Email
waltzpeebles@wisc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Effectiveness of Juveena™ Hydrogel System Following TCGP At High-Risk for Intrauterine Adhesions

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