PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery

Completed

• Conditions: Adhesion
• Interventions: Device: ADEPT

• Registration Number: NCT05811585
• Lead Sponsor: Baxter Healthcare Corporation

Brief Summary

Postoperative adhesions develop in most patients after gynecologic surgery, likely resulting in significant morbidity, complications, and considerable increases in healthcare costs. Good surgical techniques, including a minimally invasive approach, may reduce adhesions and minimize the abovementioned complications. The agents for prevention or reduction of adhesion formation are placed inside the abdominal cavity, and especially in the pelvic cavity, which contains the female reproductive organs. ADEPT Adhesion Reduction Solution, hereinafter referred to as ADEPT, is intended for use as an intraperitoneal instillate for the reduction of adhesions following gynecological laparoscopic surgeries. The objective of this study is to evaluate the effectiveness and safety of ADEPT by detecting the incidence of adhesion-related morbidities (adhesion-related readmissions, including reoperations) after laparoscopic gynecologic surgery through a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Study First Posted: 2023-04-13
• Study Start: 2023-06-26
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 153

Inclusion Criteria

• Adult female patients who, at the time of surgery, were ≥ 18 years of age and who had undergone an index laparoscopic gynecologic surgery at least 2 years prior to the start of the study.
• Patients in whom ADEPT® was used as an irrigant during the index laparoscopic gynecologic surgical procedure and as an intraperitoneal instillate for the reduction of adhesions following laparoscopic surgery.

Exclusion Criteria

• Patients who had frank infection in the abdominopelvic cavity at the time of the surgery.
• Patients who were pregnant or nursing at the time of the surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient of a Laparoscopic Gynecologic Surgery	ADEPT	ADEPT administered intraperitoneally as a liquid, used for irrigation throughout the procedure and for final instillation of a suitable amount at the end of the procedure.

Primary Outcome Measures

Name	Time	Method
Incidence of hospital readmissions directly or possibly related to adhesions	Within 2 years of surgery	Patient charts will be reviewed to collect 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 (gynecological operations, abdominal surgery, and non-operative readmissions); * Open or laparoscopic reoperations that could potentially be complicated by present adhesions.

Trial Locations

Locations (2)

Pius Hospital Oldenburg; 🇩🇪 Oldenburg, Germany

Texas Fertility Center; 🇺🇸 Austin, Texas, United States