MedTrace Logo

Safety and Effectiveness of Juveena™ Hydrogel System Following Transcervical Gynecologic Procedures (TCGP) At High-Risk for Intrauterine Adhesions

NCT05394662 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Intrauterine Adhesion

Interventions

DEVICE

Juveena Hydrogel System

Application of a novel hydrogel immediately following the transcervical procedure

PROCEDURE

Transcervical Gynecologic Procedures (TCGP)

Hysteroscopic adhesiolysis or hysteroscopic myomectomy

Sponsors & Collaborators

  • Rejoni Inc.

    lead INDUSTRY

Principal Investigators

  • Ian Feldberg · Rejoni Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-11
Primary Completion
2025-04-23
Completion
2025-04-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05394662 on ClinicalTrials.gov