Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic S… (NCT00562471) | Clinical Trial Compass
CompletedPhase 1/2
Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation
The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove myomas
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Preoperatively, subjects must have had:
* Been scheduled for myomectomy via laparotomy or laparoscopy.
* Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 6 to 8 weeks following myomectomy.
* Been \>=18 years of age.
* Provided voluntary written informed consent.
* Been willing to comply with all aspects of the treatment and evaluation schedule.
Intra-operatively, subjects must have had:
* Had at least one 2 cm incision length on posterior uterine surface, which may include the fundal surface.
Exclusion Criteria:
Preoperatively, subjects must not have had:
* Been pregnant.
* Had a pelvic malignancy.
* Had acute pelvic inflammatory disease.
* Had an immune compromised condition.
* Been a participant in another clinical research study which the investigator believed could interfere with the purpose of this study.
* Been given corticosteroids intra-operatively or during the course of the postoperative study follow up.
Intra-operatively, subjects must not have had:
* Had a pelvic malignancy.
* Had a pelvic or abdominal infection.
* Had acute pelvic inflammatory disease.
* Received any adhesion prevention adjuvants or barriers, or peritoneal instillates containing corticosteroids, NSAIDs, or Dextran.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
modified American Fertility Society (mAFS) score at the posterior uterus
Timeframe: 6-8 weeks following primary myomectomy surgery