PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery

Adhesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05811585
• Other study ID #: BXU562080
• Status: Recruiting
• Start date: June 26, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: Baxter Healthcare Corporation
• Contact: Baxter Clinical Trials Disclosure Call Center
• Phone: (224) 948-7359
• Email: Global_CORP_ClinicalTrialsDisclosure[@]baxter.com
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adhesion
• Tissue Adhesions

Intervention

Device:
• ADEPT
Adhesion Reduction Solution (4% icodextrin solution)

Locations

Country	Name	City	State
Germany	Pius Hospital Oldenburg	Oldenburg
United States	Texas Fertility Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hospital readmissions directly or possibly related to adhesions	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.	Within 2 years of surgery