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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Terumo Europe N.V.
ClinicalTrials.gov Identifier:
NCT01745432
First received: August 16, 2012
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
UTERINE MYOMAS
Device: ADBLOCK
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological Surgery

Resource links provided by NLM:


Further study details as provided by Terumo Europe N.V.:

Primary Outcome Measures:
  • Safety as evaluated by assessment of adverse events in ADBLOCK and surgery only group [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
    The rate of adverse events will be compared in treatment arm and control arm


Secondary Outcome Measures:
  • Postoperative recovery [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
  • Safety as evaluated by assessment of adverse events in ADBLOCK and surgery only group [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
  • Pain [ Time Frame: before discharge, 7d, 14d, 1mo, 3mo, 6mo, 12mo, 24mo ] [ Designated as safety issue: No ]
  • Unanticipated device-related adverse events [ Time Frame: before discharge, 7d, 14d, 1mo, 3mo, 6mo, 12mo, 24mo ] [ Designated as safety issue: Yes ]
  • Pregnancy (in women seeking to become pregnant) [ Time Frame: 3mo, 6mo, 12mo, 24mo ] [ Designated as safety issue: No ]
  • Menstrual Cycle [ Time Frame: 1m, 3mo, 6mo, 12mo, 24mo ] [ Designated as safety issue: No ]
  • Miscarriage [ Time Frame: 1mo, 3mo, 6mo, 12mo, 24mo ] [ Designated as safety issue: No ]
  • Procedure related hospital readmission [ Time Frame: 7d,14d, 1mo, 3mo, 6mo, 12mo, 24mo ] [ Designated as safety issue: Yes ]
  • Impact of covariates / Including length of pneumoperitoneum [ Time Frame: before discharge, 7d,14d, 1mo, 3mo, 6mo, 12mo, 24mo ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADBLOCK +laparoscopic surgery
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
Other Name: Adhesion Barrier System
No Intervention: laparoscopic surgery
Laparoscopic surgery only without use of adhesion barrier

Detailed Description:

Title: Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological surgery

Design: Randomised controlled study to assess the safety, manageability and usability of ADBLOCK when used as an adjunct to laparoscopic surgery for the primary removal of ('virgin') myomas in women wishing to improve pregnancy outcomes.

Use of ADBLOCK will be assessed against laparoscopic surgery alone in 30 patients (randomised 2:1 ADBLOCK/surgery) with a pneumoperitoneum ≤90minutes.

Clinical Site Locations:

  • Oldenburg, Germany
  • Neuss, Germany
  • Berlin, Germany

Patient Population: Women who have not completed their family planning and who are undergoing primary ('virgin') laparoscopic myomectomy with an aim to improve pregnancy outcomes.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • 18-45 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.

Exclusion Criteria:

  • Pre-Operative Exclusion Criteria:
  • Women who have completed their family planning
  • Current pregnancy including ectopic pregnancy
  • Breastfeeding
  • 6 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

    ->4 myoma larger than 2 cms on preoperative ultrasound screen

  • Largest myoma < 2 cms or > 8 cms diameter on pre-operative screen -GNRH agonist/antagonist treatment (except oral contraceptive - combined oestrogen/progesterone) in the 4 weeks prior to study
  • Prior surgery for myoma
  • Previous bowl surgery, excluding appendectomy
  • Prior intra-abdominopelvic adhesive complications Intraoperative Exclusion Criteria
  • Clinical evidence of cancer
  • Clinical evidence of pregnancy including ectopic pregnancy
  • Clinical evidence of rectovaginal endometriosis
  • Clinical evidence of endometriosis American Fertility Society (AFS) class III or IV
  • Use, during this procedure, of any approved or unapproved product or strategy for the purpose of preventing adhesion formation including use of O2 enhanced insufflation
  • If the procedure needs to be performed by a laparotomy (decision made after laparoscopy has commenced) the patient must be withdrawn
  • Any unplanned surgery which involves opening of the bowel or urinary tract
  • Where hysteroscopy is required and it cannot be delayed until after removal of fibroid
  • Only pedunculated fibroids
  • Extensive pelvic adhesions (AFS severe adhesion score) or frozen pelvis
  • Adhesions that would require lysing during planned myomectomy surgery Other than inconsequential filmy adhesions that do not require specific lysing to access operative site
  • If pneumoperitoneum exceeds 90 minutes duration the patient will be assessed as a separate surgical covariate group for secondary endpoints only
  • Use of fibrin glue
  • Detection of myoma which are not suitable for surgery during the study procedure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745432

Locations
Germany
Klinik für Minimal Invasive Chirurgie
Berlin, Germany, 14129
Johanna Etienne Krankenhaus Neuss
Neuss, Germany, 41462
Pius Krankenhaus Oldenburg
Oldenburg, Germany, 26121
Sponsors and Collaborators
Terumo Europe N.V.
Investigators
Principal Investigator: Rudy-Leon De Wilde, MD PhD Pius Krankenhaus Oldenburg
  More Information

No publications provided

Responsible Party: Terumo Europe N.V.
ClinicalTrials.gov Identifier: NCT01745432     History of Changes
Other Study ID Numbers: T201E4
Study First Received: August 16, 2012
Last Updated: December 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Terumo Europe N.V.:
ADBLOCK
Adhesion Barrier System
laparoscopic surgery
myomectomy

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 22, 2014