Intrauterine AdhesionPhase 3NCT05394662
Safety and Effectiveness of Juveena™ Hydrogel System Following Transcervical Gynecologic Procedures (TCGP) At High-Risk for Intrauterine Adhesions
A Phase 3 study testing Juveena Hydrogel System and Transcervical Gynecologic Procedures (TCGP) in people with Intrauterine Adhesion, run by Rejoni Inc. at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- Juveena Hydrogel System and Transcervical Gynecologic Procedures (TCGP)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 15 sitesUnited States
- Study dates
- 11 Aug 2022to 23 Apr 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
The University of Texas at Austin Dept of Womens' Health
Austin, Texas, 78712
Texas Fertility Center
Austin, Texas, 78731
Maimonides Medical Center
Brooklyn, New York, 11219
Prisma Health, Greensville Memorial Hospital
Greenville, South Carolina, 29605
Aspire Houston Fertility Institute
Houston, Texas, 77063
University Hospitals Landerbrook
Mayfield Heights, Ohio, 41124
Generations Fertility Care
Middleton, Wisconsin, 53562
Duke Universtiy Health System
Morrisville, North Carolina, 27560
Newton Wellesley Hospital
Newton, Massachusetts, 02462
Dr. Charles Miller and Associates
Park Ridge, Illinois, 60068
Arizona Gynecology Consultants
Phoenix, Arizona, 85020
UCSF Center for Reproductive Health
San Francisco, California, 94158
Boston IVF
Waltham, Massachusetts, 02451
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Cypress Medical Research Center
Wichita, Kansas, 67226
About this study
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
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.
Read the 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.
- Conditions
- Intrauterine Adhesion
- Being tested
- Juveena Hydrogel System, Transcervical Gynecologic Procedures (TCGP)
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juveena Hydrogel SystemDevice
Application of a novel hydrogel immediately following the transcervical procedure
Transcervical Gynecologic Procedures (TCGP)Procedure or surgery
Hysteroscopic adhesiolysis or hysteroscopic myomectomy
| Study group | Role | What they receive |
|---|---|---|
| Transcervical Gynecological Procedure + Juveena Hydrogel | Experimental | Transcervical Gynecological Procedure + Juveena Hydrogel Receives: Device: Juveena Hydrogel System; Procedure: Transcervical Gynecologic Procedures (TCGP) |
| Transcervical Gynecological Procedure alone (standard of care) | Active comparator | Transcervical Gynecological Procedure alone (standard of care) Receives: Procedure: Transcervical Gynecologic Procedures (TCGP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from intrauterine adhesions (IUA)
Incidence of No IUA at second look hysteroscopy (SLH)
Measured: 8 weeks
Secondary outcomes (2)
Severity of IUA
Severity of IUA classified according to March criteria at SLH
Measured: 8 weeks
Freedom of IUA with superiority margin of 5% over control at IUA
Incidence of No IUA with superiority margin of 5% over control
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start11 Aug 2022
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrauterine AdhesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Juveena Hydrogel vs No Hydrogel
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rejoni Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ian Feldberg, Study director, Rejoni Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394662
- Sponsor's protocol ID
- REJ-CT-0003
- Status last verified
- Apr 2026
- First submitted
- 24 May 2022
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Salazar CA, Chudnoff SG, Roy KH, Huddleston HG, Bhagavath B, Movilla PR, Bortoletto P, Grainger DA, Miller CE, Flyckt R, Sobolewski CJ, Livers N, Robinson JK 3rd, Morozov VV, Robinson EF, Feldberg IB, Fagnant AM, Munro MG. Safety and effectiveness of an in situ-forming hydrogel barrier in preventing intrauterine adhesions after adhesiogenic hysteroscopic procedures: a multicenter, randomized, controlled trial. Fertil Steril. 2026 Jul 23:S0015-0282(26)00571-6. doi: 10.1016/j.fertnstert.2026.07.015. Online ahead of print.
PubMed 42492609
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05394662
- Acronym / sponsor ID
- REJ-CT-0003
- Conditions
- Intrauterine Adhesion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Rejoni Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Juveena Hydrogel vs No Hydrogel
| Arm | Type | Receives |
|---|---|---|
| Transcervical Gynecological Procedure + Juveena Hydrogel | Experimental | Device: Juveena Hydrogel System, Procedure: Transcervical Gynecologic Procedures (TCGP)Transcervical Gynecological Procedure + Juveena Hydrogel |
| Transcervical Gynecological Procedure alone (standard of care) | Active comparator | Procedure: Transcervical Gynecologic Procedures (TCGP)Transcervical Gynecological Procedure alone (standard of care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Premenopausal
- Candidate for one of the following hysteroscopic procedures:
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Juveena Hydrogel SystemApplication of a novel hydrogel immediately following the transcervical procedure | Device | Transcervical Gynecological Procedure + Juveena Hydrogel |
| Transcervical Gynecologic Procedures (TCGP)Hysteroscopic adhesiolysis or hysteroscopic myomectomy | Procedure or surgery | Transcervical Gynecological Procedure + Juveena Hydrogel, Transcervical Gynecological Procedure alone (standard of care) |
Primary outcome
Freedom from intrauterine adhesions (IUA)
Time frame: 8 weeks
Incidence of No IUA at second look hysteroscopy (SLH)
2 secondary outcomes
Severity of IUA
Time frame: 8 weeks
Freedom of IUA with superiority margin of 5% over control at IUA
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Derived from this study: PubMed 42492609Salazar CA, Chudnoff SG, Roy KH, Huddleston HG, Bhagavath B, Movilla PR, Bortoletto P, Grainger DA, Miller CE, Flyckt R, Sobolewski CJ, Livers N, Robinson JK 3rd, Morozov VV, Robinson EF, Feldberg IB, Fagnant AM, Munro MG. Safety and effectiveness of an in situ-forming hydrogel barrier in preventing intrauterine adhesions after adhesiogenic hysteroscopic procedures: a multicenter, randomized, controlled trial. Fertil Steril. 2026 Jul 23:S0015-0282(26)00571-6. doi: 10.1016/j.fertnstert.2026.07.015. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Feldberg study director
Rejoni Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Juveena Hydrogel System and Transcervical Gynecologic Procedures (TCGP) in people with Intrauterine Adhesion, run by Rejoni Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from intrauterine adhesions (IUA) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05394662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.