PMCF Study for COSEAL® in Gynecologic Surgery

Adhesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05996809
• Other study ID #: BXU571781
• Status: Active, not recruiting
• Start date: February 23, 2024
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adhesion
• Tissue Adhesions

Intervention

Device:
• Coseal
Adhesion reduction

Locations

Country	Name	City	State
Italy	Universita Campus Bio Medico di Roma	Rome
United States	Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hospital readmissions directly or possibly related to adhesions following the use of COSEAL in gynecologic surgery, approximately 2 years from the date of index surgery.	Patient charts will be reviewed to collect the data on readmissions related to adhesions, which are defined as: Directly related to adhesions (adhesiolysis, non-operative readmissions for adhesions, and adhesiolysis operations on female reproductive tract); Possibly related to adhesions (gynecologic operations, abdominal surgery, and nonoperative readmissions); Open or laparoscopic reoperations that could potentially be complicated by present adhesions	within 2 years of surgery