Status:
COMPLETED
PMCF Study for COSEAL® in Gynecologic Surgery
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Adhesion
Eligibility:
FEMALE
18+ years
Brief Summary
The study is a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart, when necessary. The population will consist of patients who underwent an i...
Eligibility Criteria
Inclusion
- Adult female patients who, at the time of surgery, were ≥18 years of age and who have undergone an index gynecologic surgery at least 2 years prior to the start of the study.
- Patients in whom COSEAL was used for the reduction of post-surgical adhesion formation
Exclusion
- 1\. Patients who had frank infection in the abdominopelvic cavity at the time of the surgery
Key Trial Info
Start Date :
June 3 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 8 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05996809
Start Date
June 3 2024
End Date
May 8 2025
Last Update
August 3 2025
Active Locations (2)
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1
Feinberg School of Medicine
Chicago, Illinois, United States, 60611
2
Universita Campus Bio Medico di Roma
Rome, Rome, Italy, 00128