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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02260115 |
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Date of registration:
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01/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Randomized Multi-centre Study to Assess the Safety and Manageability of a Laparoscopic Adhesion Barrier in Women Undergoing Gynecologic Laparoscopic Surgery Followed by Second Look Laparoscopy
LABS-1 |
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Scientific title:
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A Randomized, Controlled, Subject and Reviewer-Blinded, Multi-Centre Study To Assess The Safety and Manageability Of LABS™ In Women Undergoing Gynaecologic Laparoscopic Surgery Followed By Second Look Laparoscopy |
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Date of first enrolment:
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November 2013 |
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Target sample size:
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78 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02260115 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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Germany
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Greece
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Contacts
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Name:
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Rudy DeWilde, MD, ScD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Professor and Head Department of Gynecology, Obstetrics and Gynecology Oncology, Pius-Hospital |
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Name:
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Geoffery H Trew, M.B.B.S |
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Address:
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Telephone:
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Email:
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Affiliation:
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Consultant in Reproductive Medicine and Surgery, Hammersmith Hospital |
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Name:
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Sara Y Brucker, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Deputy Head of Department of Gynecology and Obstetrics, University of Tubingen Women's Hospital |
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Name:
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George A Pistofidis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Director Department of Gynaecological Surgery Lefkos, Stavros Hospital |
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Name:
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Matthias Korell, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Head Department of Obstetrics and Gynecology, Johanna Etienne-Krankenhaus |
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Key inclusion & exclusion criteria
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PREOPERATIVE INCLUSION
Preoperatively the patient must:
- understand and be able to follow the requirements of the protocol including signing
and dating an Ethics Committee approved Informed Consent prior to undergoing any
protocol related procedures
- be a premenopausal female who is > 18 and < 46 years old
- be thought to have gynaecologic pathology requiring laparoscopic surgery - including
uterine fibroids (including those with only anterior fibroid or repeat
myomectomy/previous uterine artery embolization for fibroid), adhesions, and/or
endometriosis with or without associated pathology such as ovarian cysts
- wish to retain her fertility
- and thus be considered to clinically benefit from a second-look laparoscopic
procedure;
- have a willingness to undergo a second-look surgical procedure if clinically indicated
- have a negative pregnancy test within 5 days of surgery
- agree to avoid pregnancy using adequate forms of contraception through the time of
performance of second-look laparoscopy (oral contraceptive pill, condom, no sexual
intercourse), and if the patient is undergoing myomectomy that she is aware that it is
good advice to avoid pregnancy for a 12 week period to allow healing of the uterine
scar before becoming pregnant
- be in good health including an ASA (American Society of Anaesthesiologists) score of 2
or less
- following physical and medical assessment have no clinically significant or relevant
abnormalities.
PREOPERATIVE EXCLUSION
Preoperatively a patient must not:
- be unable to give their own written informed consent,
- have completed her family planning with no desire to maintain fertility,
- be considered to have no potential clinical benefit from a second look laparoscopy,
- be breastfeeding,
- be within 6 weeks post-partum
- have received or is expected to receive another anti-adhesive treatment within 30 days
prior to enrolment or during enrolment up to adhesion evaluation at second look
laparoscopy,
- be currently enrolled in another clinical study or has been in another study within
the last 30 days,
- have received or is expected to receive any other investigational product or technique
within 30 days prior to or during enrolment,
- have had cancer within 5 years of the initial surgery with the exception of basal cell
carcinoma,
- have known allergy to dextran, PEG, or FD&C Blue #1,
- be scheduled to undergo concomitant non-gynaecological surgery,
- be currently pregnant (including ectopic pregnancy),
- have received GNRH agonist/antagonist, Depo Provera, danocrine, ulipristal acetate or
similar treatment (except oral contraceptives - and including progesterone only) in
the 4 weeks prior to study,
- on pre-operative imaging have
- Largest fibroid < 2 cms
- Or largest fibroid > 10 cms diameter intramural
- Or more than 5 large fibroids (large = >8 cms diameter)
- And/or adenomyoma >10cm identified
- have a history where it is expected that complete adhesiolysis will not be possible,
- preoperatively have clinically significant abnormal blood results including:
- SGOT, SGPT and/or bilirubin > 20% above the upper range of normal and/or
- BUN and creatinine > 30% above the upper range of normal,
- have clinically relevant hemochromatosis, hepatic, renal, autoimmune, lymphatic,
haematological or coagulation disorders,
- have insulin dependent diabetes mellitus,
- be receiving concurrent systemic corticosteroids, antineoplastic agents and/or
radiation therapy,
- have had previous radiation therapy,
- have active pelvic or abdominal infection, or other active infection with fever >38°C.
INTRAOPERATIVE INCLUSION
During surgery the patient must have:
• treatment of uterine fibroids, endometriosis, and or adhesions, with or without
associated pathology such as ovarian cysts, and meets all intraoperative
inclusion/exclusion criteria prior to randomisation, including that a SLL is clinically
indicated
Additionally for the myomectomy sub study, during surgery it must be confirmed that:
- the patient underwent a laparoscopic myomectomy with at least (1) posterior uterine
serosal incision of > 3 cm in length
- that the major portion of the procedure (in the opinion of the surgeon) was related to
myomectomy
- that the patient meets all intraoperative inclusion/exclusion criteria prior to
randomisation.
and
• at the completion of the procedure, prior to randomisation, the surgeon continues to
believe that the patient will clinically benefit from second- look laparoscopy.
INTRAOPERATIVE EXCLUSION
Intraoperatively a patient must not:
- have cancer detected at surgery,
- be pregnant, including ectopic pregnancy,
- have a non-gynaecological surgical procedure or entry into the bowel, bladder, or
ureter,
- have a hysterectomy or other gynaecological procedure that would render the patient
unable to conceive
- receive the administration of a product that will interfere with the application of
LABS™ Adhesion Barrier Material,
- receive the use of an approved or unapproved product or strategy for the purpose of
preventing adhesion development,
- receive fibrin glue, surgical sealant, or other haemostatic agent,
- undergo an open procedure
- undergo a posterior colpotomy,
- undergo insufflation with a gas other than CO2,
- undergo Laprolift or similar device for elevation of the abdominal wall, as an
alternative to CO2 insufflation,
- undergo abdominal cavity humidification or oxygenation,
- undergo robotic surgery,
- receive irrigants containing, glucocorticoids, antihistamines, heparin or antiseptic
additives.
- have a postoperative drain
- does not have complete lysis of any adhesions to the posterior uterus
- has deep infiltrating endometriosis that is not treated during surgery
- patient had ovarian cysts with no other pathology
- be considered to have no clinical indication for a SLL
For the myomectomy sub study the patient:
- does not undergo laparoscopic myomectomy with at least (1) posterior uterine serosal
incision of > 3 cm in length,
- has only pedunculat
Age minimum:
18 Years
Age maximum:
46 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Tissue Adhesions
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Intervention(s)
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Device: LABS™
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Procedure: Surgical Control
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Primary Outcome(s)
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Incidence of adverse events, abnormal changes in vital signs and/or clinical laboratory measures
[Time Frame: Between baseline initial surgery and second look laparoscopy (4-12 weeks)]
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Secondary Outcome(s)
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Surgeon satisfaction with the device and it's application
[Time Frame: During baseline initial surgery]
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Secondary ID(s)
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ABS-01EU-2013
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95.10 - 5660 - 7811
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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