NCT05996809

PMCF Study for COSEAL® in Gynecologic Surgery

Post-Market Clinical Follow-up Study for COSEAL® in Gynecologic Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Coseal	Adhesion reduction

Timeline

• Start date: 2024-06-03
• Primary completion: 2025-05-08
• Completion: 2025-05-08
• First posted: 2023-08-18
• Last updated: 2025-08-03

Locations

2 sites across 2 countries: United States, Italy

Regulatory

• FDA-regulated device study