A Randomized Multi-centre Study to Assess the Safety and Manageability of a Laparoscopic Adhesion Barrier in Women Undergoing Gynecologic Laparoscopic Surgery Followed by Second Look Laparoscopy

NCT02260115 | Completed Phase 1 DMC

• 2 other identifiers: ABS-01EU-201395.10 - 5660 - 7811
• Study Type: interventional
• Target: 78
• Locations: 2 countries
• Sites: 4

Brief Summary

The purpose of this study is to obtain data on the safety and manageability of applying LABS™ to the uterus and other areas of surgical trauma in the pelvis and abdomen following laparoscopic gynaecologic surgery. In addition, performance data following a clinical indicated second look laparoscopy will be collected for the purpose of determining sample size predictions for future trials.

Conditions

Tissue Adhesions

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events, abnormal changes in vital signs and/or clinical laboratory measures

  Between baseline initial surgery and second look laparoscopy (4-12 weeks)

Secondary Outcomes (1)

• Surgeon satisfaction with the device and it's application

  During baseline initial surgery

Other Outcomes (3)

• Patients with myomectomy

  Baseline initial surgery to second look laparoscopy (4-12 weeks)

• Change in adhesion score of patients with other gynecological pathology

  Baseline initial surgery to second look laparoscopy (4-12 weeks)

• Other adhesion parameters

  Baseline initial surgery to second look laparoscopy (4-12 weeks)

Study Arms (2)

LABS™

EXPERIMENTAL

hydrogel sprayed laparoscopically over all pelvic areas of surgical trauma

Device: LABS™

Surgical Control

SHAM COMPARATOR

Laproscopic Surgery Only

Procedure: Surgical Control

Interventions

LABS™ DEVICE

hydrogel sprayed laparoscopically over all pelvic areas of surgical trauma

LABS™

Surgical Control PROCEDURE

Surgery only

Surgical Control

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Additionally for the myomectomy sub study, during surgery it must be confirmed that:
• the patient underwent a laparoscopic myomectomy with at least (1) posterior uterine serosal incision of \> 3 cm in length
• that the major portion of the procedure (in the opinion of the surgeon) was related to myomectomy
• and
• at the completion of the procedure, prior to randomisation, the surgeon continues to believe that the patient will clinically benefit from second- look laparoscopy.
• Intraoperatively a patient must not:
• have cancer detected at surgery,
• be pregnant, including ectopic pregnancy,
• have a non-gynaecological surgical procedure or entry into the bowel, bladder, or ureter,
• have a hysterectomy or other gynaecological procedure that would render the patient unable to conceive
• receive the administration of a product that will interfere with the application of LABS™ Adhesion Barrier Material,
• receive the use of an approved or unapproved product or strategy for the purpose of preventing adhesion development,
• receive fibrin glue, surgical sealant, or other haemostatic agent,
• undergo an open procedure
• undergo a posterior colpotomy,

Sponsors & Collaborators

• Actamax Surgical Materials LLC: lead

Study Sites (4)

Johanna Etienne Krankenhaus

Neuss, Germany

Location

Pius-Hosptial, European Medical School Oldenburg-Groningen, Carl von Ossietzky University

Oldenburg, Germany

Location

University of Tubingen Women's Hosptial

Tübingen, Germany

Location

Lefkos Stavros Hospital

Athens, Greece

Location

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rudy DeWilde, MD, ScD, PhD

  Professor and Head Department of Gynecology, Obstetrics and Gynecology Oncology, Pius-Hospital

  PRINCIPAL INVESTIGATOR

• Sara Y Brucker, MD, PhD

  Deputy Head of Department of Gynecology and Obstetrics, University of Tubingen Women's Hospital

  PRINCIPAL INVESTIGATOR

• Matthias Korell, MD

  Head Department of Obstetrics and Gynecology, Johanna Etienne-Krankenhaus

  PRINCIPAL INVESTIGATOR

• George A Pistofidis, MD

  Director Department of Gynaecological Surgery Lefkos, Stavros Hospital

  PRINCIPAL INVESTIGATOR

• Geoffery H Trew, M.B.B.S

  Consultant in Reproductive Medicine and Surgery, Hammersmith Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 9, 2014
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2016
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

DE (3); GR (1)