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NCT00697606 · ClinicalTrials.gov registry record · Phase 3
Seprafilm® for Prevention of Adhesions at Repeat Cesarean
A Phase 3 study, sponsored by Abington Memorial Hospital.
- Terminated
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
NCT00697606 is a Phase 3 study that was terminated before completion, run by Abington Memorial Hospital. The registered enrollment target is 450 participants.
The verdict
NCT00697606, a Phase 3 study, was terminated before completion, sponsored by Abington Memorial Hospital.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
Study Summary
Adhesion formation is a result of abdominal and pelvic surgery and is a cause of such diseases as chronic pain syndrome, bowel obstruction and infertility. Both patients and surgeons suffer when adhesions are encountered, since the surgery becomes more intense, lengthy, and complicated. Seprafilm® has been shown to limit the formation of adhesions in gynecologic and abdominal surgery. Limited data is available on the effectiveness of Seprafilm® in the prevention of abdominal wall and pelvic adhesions at the time of cesarean section. Adhesions at the time of repeat cesarean make the surgery frustrating and complex, with difficult lysis of adhesions being the cause of morbidities such as bladder damage, increased blood loss, and longer operating times. The objective of this definitive project is to define the extent of reduction of adhesion formation of Seprafilm® when used at the time of primary cesarean section. Women undergoing primary cesarean section will be randomized for Seprafilm® application, and the incidence and grade of adhesions at repeat cesarean will be determined.
Interventions
- OTHER Control
- DEVICE Seprafilm®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2008-07 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00697606
The ClinicalTrials.gov registry entry for NCT00697606 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abington Memorial Hospital, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT00697606 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00697606 about?
NCT00697606 is a clinical study titled "Seprafilm® for Prevention of Adhesions at Repeat Cesarean". Adhesion formation is a result of abdominal and pelvic surgery and is a cause of such diseases as chronic pain syndrome, bowel obstruction and infertility. Both patients and surgeons suffer when adhesions are encountered, since the surgery becomes more intense, lengthy, and complicated. Seprafilm® h...
What is the current status of trial NCT00697606?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2008-07. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00697606?
The interventions under investigation include: Control (OTHER), Seprafilm® (DEVICE).
Who is sponsoring clinical trial NCT00697606?
This trial is sponsored by Abington Memorial Hospital, which has 2 total clinical trials registered on ClinicalTrials.gov.
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