PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery

Completed

Conditions studied: Adhesion

In brief

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.

Key facts

Study ID

NCT05811585

Run by

Baxter Healthcare Corporation

People needed

153

Starts

2023-06-26

Expected to finish

2024-05-31

Last updated by the study team

2025-03-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Texas Fertility Center — Austin, Texas, United States
• Pius Hospital Oldenburg — Oldenburg, Germany

Full record on ClinicalTrials.gov

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