PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Adhesion
• Intervention / Treatment: Device: ADEPT

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Baxter Clinical Trials Disclosure Call Center; Phone Number: (224) 948-7359; Email: Global_CORP_ClinicalTrialsDisclosure@baxter.com

Study Locations

• Germany
  • Oldenburg, Germany
    • Recruiting
    • Pius Hospital Oldenburg
    • Contact: Rudy De Wilde
• United States
  • Texas
    • Austin, Texas, United States, 78731
      • Recruiting
      • Texas Fertility Center
      • Contact: Kaylen M Silverberg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The population will consist of patients who underwent an index laparoscopic gynecologic surgery (performed at least 2 years prior to the start of the study) during which ADEPT (4% icodextrin solution) was used as an irrigant during the index laparoscopic gynecologic surgical procedure and as an intraperitoneal instillate for the reduction of adhesions.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient of a Laparoscopic Gynecologic Surgery; 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.	Device: ADEPT; Adhesion Reduction Solution (4% icodextrin solution)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Estimated): April 15, 2024
• Study Completion (Estimated): April 15, 2024

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopic gynecologic surgery; adhesion-related morbidities
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: BXU562080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
• IPD Sharing Time Frame: Upon approval of a legitimate research request.
• IPD Sharing Access Criteria: Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No