Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological Surgery

NCT01745432 | Completed Phase 1 DMC

• 1 other identifier: T201E4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

Adhesions are the most frequent complication of abdominopelvic surgery. They are internal scar tissues which form as a result of surgery which may abnormally join together what were once separate tissues and organs. This study will assess the safety and usability of anti-adhesion agent (gel) when used after laparoscopic surgery. The study will enroll 30 patients, (randomised 2:1) with safety primary endpoint (adverse events in ADBLOCK and surgery only group) assessed at 28 days

Conditions

UTERINE MYOMAS

Keywords

ADBLOCK; Adhesion Barrier System; laparoscopic surgery; myomectomy

Outcome Measures

Primary Outcomes (1)

• Safety as evaluated by assessment of adverse events in ADBLOCK and surgery only group

  The rate of adverse events will be compared in treatment arm and control arm

  up to 28 days

Secondary Outcomes (9)

• Postoperative recovery

  up to 28 days

• Safety as evaluated by assessment of adverse events in ADBLOCK and surgery only group

  up to 24 months

• Pain

  before discharge, 7d, 14d, 1mo, 3mo, 6mo, 12mo, 24mo

• Unanticipated device-related adverse events

  before discharge, 7d, 14d, 1mo, 3mo, 6mo, 12mo, 24mo

• Pregnancy (in women seeking to become pregnant)

  3mo, 6mo, 12mo, 24mo

Study Arms (2)

ADBLOCK +laparoscopic surgery

EXPERIMENTAL

Adhesion Barrier System is site-specific sprayable adhesion barrier gel administered on the surgical field to reduce risk of adhesion formation.

Device: ADBLOCK

laparoscopic surgery

NO INTERVENTION

Laparoscopic surgery only without use of adhesion barrier

Interventions

ADBLOCK DEVICE

Laparoscopic surgery

Also known as: Adhesion Barrier System

ADBLOCK +laparoscopic surgery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• years
• Indication for laparoscopic myomectomy according to the medical standard
• Negative pregnancy test before study entry
• Using adequate forms of contraception for 12 weeks following surgery (e.g. oral contraceptive pill, condom, no sexual intercourse)
• In good health including an ASA (American Society of Anesthesiologists) score of 2 or less
• No clinically significant and relevant abnormalities as evaluated by satisfactory medical assessment
• Planned de novo removal of myoma (includes mural and combination of mural and pedunculated myoma)
• Willing, able and likely to fully comply with study procedures and restrictions
• Given written, personally signed and dated informed consent to participate in the study as approved by the Institutional Review Board/Ethics Committee of the respective Clinical Study Site.

You may not qualify if:

• Women who have completed their family planning
• Current pregnancy including ectopic pregnancy
• Breastfeeding
• weeks post-partum
• Participation in another clinical study currently or within the last 30 days prior to enrolment
• SGOT, SGPT and/or bilirubin \> 20% above the upper range of normal and considered clinically significant
• BUN and creatinine \> 30% above the upper range of normal and considered clinically significant
• Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation
• Previous radiation therapy
• Diabetes
• Clinically relevant haemochromatosis, hepatic, renal, autoimmune, lymphatic, haematological or coagulation disorders
• Active pelvic or abdominal infection, or other infection with fever (\>38°C)
• Extensive keloid scarring
• Known allergy to starch-based polymers
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of the stated ingredients -Additional surgical procedure non-obstetrics and gynaecology (non- OB/GYN) planned to be performed during the laparoscopic procedure

Sponsors & Collaborators

• Terumo Europe N.V.: lead

Study Sites (3)

Klinik für Minimal Invasive Chirurgie

Berlin, 14129, Germany

Location

Johanna Etienne Krankenhaus Neuss

Neuss, 41462, Germany

Location

Pius Krankenhaus Oldenburg

Oldenburg, 26121, Germany

Location

Study Officials

• Rudy-Leon De Wilde, MD PhD

  Pius Krankenhaus Oldenburg

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: December 10, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

DE (3)