PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05811585
Study type	Observational
Source	Baxter Healthcare Corporation
Contact	Baxter Clinical Trials Disclosure Call Center
Phone	(224) 948-7359
Email	Global_CORP_ClinicalTrialsDisclosure@baxter.com
Status	Recruiting
Phase
Start date	June 26, 2023
Completion date	April 15, 2024

View Details

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