Clinical trial · Interventional
Seprafilm™ for the Prevention of Intraperitoneal Adhesions and Improved Delivery of Therapy in Women Undergoing Staging and Intraperitoneal Chemotherapy for Advanced Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): due to company changes and lack of funding-unlikely to have sufficient numbers to analyze meaningfully
Summary
Brief summary (as posted)
The purpose of this research is to determine if a film to prevent adhesions will improve the area of distribution of a contrast dye (representative of chemotherapy) in the abdominal cavity (belly) of women who have undergone surgery for ovarian cancer as compared with patients who have not had adhesion barrier sheets placed in the belly. It is believed that this film, Seprafilm™, reduces adhesions (scar tissue between tissues and organs) in the abdominal cavity following surgery. Adhesions can limit the distribution of the chemotherapy agent placed in the abdomen to treat the ovarian cancer. Thirty subjects will receive adhesion barrier sheets and thirty will not. To determine if the sheets prevent adhesions, all subjects will have a dye inserted into the abdomen and then have X-rays of the abdomen to look at the distribution of the dye between the two groups. Hypothesis: Null hypothesis: There is no difference in area of distribution of the intraperitoneal dye in the Seprafilm ™ vs. no Seprafilm™ groups. Alternative hypothesis: Seprafilm™ reduces adhesion formation and there is a larger area of distribution of intraperitoneal dye in the Seprafilm™ group.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Seprafilm™ | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Seprafilm™
- description
- Subject will have 3 sheets of Seprafilm™ placed in her abdominal cavity (in the pelvis, upper abdomen and below the incision) at the end of debulking surgery. At 7-21 days after surgery the subject will receive a contrast dye, Iohexol (Omnipaque™), into her intraperitoneal port. The subject will then undergo 3 abdominal X-rays, to assess the extent of abdominal adhesions.
- interventionNames
- Procedure: Seprafilm™
- type
- NO_INTERVENTION
- label
- No Seprafilm™
- description
- Subject will undergo debulking surgery without Seprafilm™ placement (standard care). At 7-21 days after surgery the subject will receive a contrast dye, Iohexol (Omnipaque™), into her intraperitoneal port. The subject will then undergo 3 abdominal X-rays, to assess the extent of abdominal adhesions.
Primary outcomes (1)
- measure
- The area of distribution of contrast dye in the intraperitoneal cavity as measured on three abdominal films taken 7-10 days following debulking surgery for epithelial ovarian cancer.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Epithelial ovarian cancer * Stage III or IV (advanced) * Planned intraperitoneal chemotherapy * Optimally debulked to less than 1 cm residual tumor in any area within the peritoneal cavity (after consent prior to randomization)
References
Publications (0)
Data not yet available