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

Terumo

Status and phase

Completed

Phase 1

Conditions

UTERINE MYOMAS

Treatments

Device: ADBLOCK

Study type

Interventional

Funder types

Industry

Identifiers

NCT01745432

T201E4

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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