Juveena Hydrogel System Pivotal Study (Intrauterine Adhesions)

Purpose of this Study

We are doing this study to find out if filling the uterus with a soft, experimental material called Juveena Hydrogel (the study product) at the end of gynecological surgical procedures can safely and effectively reduce the formation or reformation of intrauterine adhesions. The device is referred to as a "hydrogel" because it is made of approximately 90% water. The other main ingredient is polyethylene glycol, or "PEG," a material that is widely used in the preparation of drugs and other medical products. The study product will gradually break down over time (within approximately 2 to 3 weeks), so no other procedure is needed to remove it.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are scheduled to undergo adhesiolysis or fibroid removal surgery
  • Have not had a previous uterine surgery for at least 2 months before joining the study
  • Have not been pregnant for at least 3 months before joining the study, or at least 6 weeks if the pregancy was lost in the first trimester
For more information, contact the study team at tifani.panek@duke.edu.

Age Range

18-110

Sex/Genders

Female (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
No

What is Involved?

Description

This study will involve at least 3 visits to Duke and 3 telephone calls, which include:
  • Screening visit: This visit is to find out if you are eligible to take part in the study. We will schedule this visit within 60 days of your planned hysteroscopic procedure.
  • Hysteroscopic procedure: You may or may not receive the hydrogel after the surgical procedure.
  • Week 1 Phone Call: We will call you 5-14 days after your procedure to see how you are doing. If you are experiencing any problems, we will ask you to come in for a clinic visit.
  • Week 3 Phone Call: We will call you 16-28 days after your procedure. If you are experiencing any problems, we will ask you to come in for a clinic visit.
  • Week 8 visit: You will visit our clinic for a check-up 6-10 weeks after your procedure.
  • End of Study Phone Call: We will call you 10-12 weeks after your procedure. If you are experiencing any problems, we will ask you to come in for a clinic visit.

Locations

Other

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full 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

Principal Investigator

Craig
Sobolewski

Protocol Number

PRO00114870

Phase

III

Enrollment Status

Open to Enrollment