NCT05811585

PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 153 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adhesion

Interventions

Type	Name	Description
DEVICE	ADEPT	Adhesion Reduction Solution (4% icodextrin solution)

Timeline

• Start date: 2023-06-26
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2023-04-13
• Last updated: 2025-03-21

Locations

2 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study