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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcervical Gynecological Procedure + Juveena Hydrogel | Experimental | Transcervical Gynecological Procedure + Juveena Hydrogel |
|
| Transcervical Gynecological Procedure alone (standard of care) | Active Comparator | Transcervical Gynecological Procedure alone (standard of care) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Juveena Hydrogel System | Device | Application of a novel hydrogel immediately following the transcervical procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from intrauterine adhesions (IUA) | Incidence of No IUA at second look hysteroscopy (SLH) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of IUA | Severity of IUA classified according to March criteria at SLH | 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 |
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Inclusion Criteria:
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.
Subject has signed the IRB/EC approved informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Feldberg | Rejoni Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Gynecology Consultants | Phoenix | Arizona | 85020 | United States | ||
| UCSF Center for Reproductive Health |
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Juveena Hydrogel vs No Hydrogel
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Subjects won't be told which group they were assigned. Primary outcome reviewed by blinded independent central review.
| Transcervical Gynecologic Procedures (TCGP) | Procedure | Hysteroscopic adhesiolysis or hysteroscopic myomectomy |
|
| 8 weeks |
| San Francisco |
| California |
| 94158 |
| United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Dr. Charles Miller and Associates | Park Ridge | Illinois | 60068 | United States |
| Cypress Medical Research Center | Wichita | Kansas | 67226 | United States |
| Newton Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| Boston IVF | Waltham | Massachusetts | 02451 | United States |
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| Duke Universtiy Health System | Morrisville | North Carolina | 27560 | United States |
| University Hospitals Landerbrook | Mayfield Heights | Ohio | 41124 | United States |
| Prisma Health, Greensville Memorial Hospital | Greenville | South Carolina | 29605 | United States |
| The University of Texas at Austin Dept of Womens' Health | Austin | Texas | 78712 | United States |
| Texas Fertility Center | Austin | Texas | 78731 | United States |
| Aspire Houston Fertility Institute | Houston | Texas | 77063 | United States |
| Generations Fertility Care | Middleton | Wisconsin | 53562 | United States |
| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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