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UTERINE MYOMASPhase 1ADBEENCT01745432

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

A Phase 1 study testing ADBLOCK in people with UTERINE MYOMAS, run by Terumo Europe N.V. at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
UTERINE MYOMAS
What is being tested?
ADBLOCK
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesGermany
Study dates
Aug 2012to Sep 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 35Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Klinik für Minimal Invasive Chirurgie

    Berlin, 14129

  • Johanna Etienne Krankenhaus Neuss

    Neuss, 41462

  • Pius Krankenhaus Oldenburg

    Oldenburg, 26121

Other trials in Germany

About this study

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

Read the 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.

Conditions
UTERINE MYOMAS
Being tested
ADBLOCK
Keywords
ADBLOCK, Adhesion Barrier System, laparoscopic surgery, myomectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADBLOCKDevice

    Also called Adhesion Barrier System

    Laparoscopic surgery

Study groups in NCT01745432
Study groupRoleWhat they receive
ADBLOCK +laparoscopic surgeryExperimentalAdhesion Barrier System is site-specific sprayable adhesion barrier gel administered on the surgical field to reduce risk of adhesion formation.
Receives: Device: ADBLOCK
laparoscopic surgeryNo interventionLaparoscopic surgery only without use of adhesion barrier

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 28 days

Secondary outcomes (9)

  1. Postoperative recovery

    Measured: up to 28 days

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

    Measured: up to 24 months

  3. Pain

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

  4. Unanticipated device-related adverse events

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

  5. Pregnancy (in women seeking to become pregnant)

    Measured: 3mo, 6mo, 12mo, 24mo

  6. Menstrual Cycle

    Measured: 1m, 3mo, 6mo, 12mo, 24mo

  7. Miscarriage

    Measured: 1mo, 3mo, 6mo, 12mo, 24mo

  8. Procedure related hospital readmission

    Measured: 7d,14d, 1mo, 3mo, 6mo, 12mo, 24mo

  9. Impact of covariates / Including length of pneumoperitoneum

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionAug 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01745432
Sponsor's protocol ID
T201E4
Acronym
ADBEE
Status last verified
Jul 2016
First submitted
16 Aug 2012
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ADBLOCK in people with UTERINE MYOMAS, run by Terumo Europe N.V. at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety as evaluated by assessment of adverse events in ADBLOCK and surgery only group (time frame: up to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01745432.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.

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