PMCF Study for COSEAL® in Gynecologic Surgery

NCT05996809 | Completed FDA Device

• 1 other identifier: BXU571781
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 2

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

Keywords

gynecological surgery, adhesion related morbidities

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Device: Coseal

Interventions

Coseal DEVICE

Adhesion reduction

Patients who underwent an index gynecologic surgery

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Data will be collected from adult female patient charts in whom COSEAL was used as an adjunct to good surgical technique to reduce the incidence, severity, and extent of post-surgical adhesion formation. Data will also be collected from the questionnaire responses, when necessary

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (2)

Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Universita Campus Bio Medico di Roma

Rome, Rome, 00128, Italy

Location

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 18, 2023
• Study Start: June 3, 2024
• Primary Completion: May 8, 2025
• Study Completion: May 8, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Upon approval of a legitimate research request.
• Access Criteria: Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.

Locations

US (1); IT (1)