PMCF Study for COSEAL® in Gynecologic Surgery

NCT ID: NCT05996809

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2025-05-08

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 index gynecologic surgery (performed at least 2 years prior to the start of the study) during which COSEAL was used as an adjunct to good surgical technique to reduce the incidence, severity, and extent of post-surgical adhesion formation. The purpose of the study is to detect the incidence of adhesion-related morbidities as measured by the proportion of adhesion-related readmissions, including reoperations in these patients.

Patient charts will be reviewed to collect the data on readmissions related to adhesions, If the patient chart has no record of adhesion related readmission within approximately 2 years of the index surgery, then a patient questionnaire will be sent. A questionnaire may still be sent if a patient chart has a record of adhesion related readmission within approximately 2 years of the index surgery and further clarification is needed. The questionnaire will collect information regarding readmission or reoperation directly or possibly related to adhesions following the index gynecologic surgical procedure at a hospital or outpatient clinic other than that of the index surgery.

Conditions

Adhesion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients who underwent an index gynecologic surgery

The population will consist of patients who underwent an index gynecologic surgery (performed at least 2 years prior to the start of the study) during which COSEAL was used

Coseal

Intervention Type: DEVICE

Adhesion reduction

Interventions

Coseal

Adhesion reduction

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patients in whom COSEAL was used for the reduction of post-surgical adhesion formation

Exclusion Criteria

1. Patients who had frank infection in the abdominopelvic cavity at the time of the surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Feinberg School of Medicine

Chicago, Illinois, United States

Universita Campus Bio Medico di Roma

Rome, Rome, Italy

Countries

United States; Italy

Other Identifiers

BXU571781

Identifier Type: -

Identifier Source: org_study_id