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NCT05394662 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Rejoni.

Completed
Registry status
Phase 3
Development phase
150
Enrollment target

NCT05394662: Completed Phase 3 study, sponsored by Rejoni.

NCT05394662 is a Phase 3 study that has completed, run by Rejoni. The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05394662, a Phase 3 study, has completed, sponsored by Rejoni.

COMPLETED
Registry status
Phase 3
Development phase
150 participants
Enrollment target

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.

Primary Outcome

Incidence of No IUA at second look hysteroscopy (SLH)

Interventions

  • DEVICE Juveena Hydrogel System
  • PROCEDURE Transcervical Gynecologic Procedures (TCGP)

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2022-08-11
Est. Completion 2025-04-23
Phase Phase 3
Rejoni

3 total trials

What the finished NCT05394662 record still lists

NCT05394662 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 2 interventions - of which Juveena Hydrogel System is the first listed.

NCT05394662 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05394662 about?

NCT05394662 is a clinical study titled "Safety and Effectiveness of Juveena™ Hydrogel System Following Transcervical Gynecologic Procedures (TCGP) At High-Risk for Intrauterine Adhesions". 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.

What is the current status of trial NCT05394662?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2022-08-11. Estimated completion is 2025-04-23.

What interventions are being tested in trial NCT05394662?

The interventions under investigation include: Juveena Hydrogel System (DEVICE), Transcervical Gynecologic Procedures (TCGP) (PROCEDURE).

Who is sponsoring clinical trial NCT05394662?

This trial is sponsored by Rejoni, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05394662's enrollment target sits among peer trials

150 1519th of 2000 higher than 455 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05394662, the US trial registry maintained by the National Library of Medicine. NCT05394662 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.