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

Phase 1
18 Years
45 Years
Open (Enrolling)

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Trial Information

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

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

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

- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

up to 28 days

Safety Issue:


Principal Investigator

Rudy-Leon De Wilde, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Pius Krankenhaus Oldenburg


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

August 2012

Completion Date:

November 2014

Related Keywords:

  • Uterine Myomas
  • Adhesion Barrier System
  • laparoscopic surgery
  • myomectomy
  • Tissue Adhesions
  • Myoma
  • Leiomyoma
  • Myofibroma