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
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