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

UTERINE MYOMAS Clinical Trial

— ADBEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745432
• Other study ID #: T201E4
• Status: Completed
• Phase: Phase 1
• First received: August 16, 2012
• Last updated: July 3, 2016
• Start date: August 2012
• Est. completion date: September 2015

Study information

• Verified date: July 2016
• Source: Terumo Europe N.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Leiomyoma
• UTERINE MYOMAS

Intervention

Device:
• ADBLOCK
Laparoscopic surgery

Locations

Country	Name	City	State
Germany	Klinik für Minimal Invasive Chirurgie	Berlin
Germany	Johanna Etienne Krankenhaus Neuss	Neuss
Germany	Pius Krankenhaus Oldenburg	Oldenburg

Sponsors (1)

Lead Sponsor	Collaborator
Terumo Europe N.V.

Country where clinical trial is conducted

Germany, 

Outcome

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