Clinical trial · Interventional
Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery
A Prospective, Controlled, Randomized, Multi-Center, Pivotal Study Evaluating the Safety and Efficacy of AdhexilTM in Prevention And/Or Reduction of Adhesions in Gynecology Surgery
NCT00865488CI-TRIAL-00002922suspendedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adhesions | — | UNRESOLVED | — |
| Endometriosis | — | UNRESOLVED | — |
| Ovarian Cysts | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADHEXIL | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- 1
- description
- patients who will be treated in accordance with standard of care
- type
- EXPERIMENTAL
- label
- 2
- description
- patients for which Adhexil will be applied to prevent/reduce adhesions
- interventionNames
- Biological: ADHEXIL
Primary outcomes (1)
- measure
- Adhesions will be assessed according to incidence, extent and severity.
- timeFrame
- 8 weeks post surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged 18-45 years at screening. * Patients undergoing elective laparoscopic surgery involving at least one adnexa. Exclusion Criteria: * Pregnant (including ectopic pregnancy) or breastfeeding patient. * Patients with a documented diagnosis of cancer. * Patients with a lymphatic, hematologic or coagulation disorder. * Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™. * Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants. * Patients who have participated in another clinical study within 30 days of enrolment. * Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study.
References
Publications (0)
Data not yet available
No reference posted for this study.