UTERINE MYOMAS
Conditions
Keywords
ADBLOCK, Adhesion Barrier System, laparoscopic surgery, myomectomy
Brief 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
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.
Interventions
DEVICEADBLOCK
Laparoscopic surgery
Sponsors
Terumo Europe N.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as evaluated by assessment of adverse events in ADBLOCK and surgery only group | up to 28 days | The rate of adverse events will be compared in treatment arm and control arm |
Secondary
| Measure | Time frame |
|---|---|
| Safety as evaluated by assessment of adverse events in ADBLOCK and surgery only group | up to 24 months |
| Pain | before discharge, 7d, 14d, 1mo, 3mo, 6mo, 12mo, 24mo |
| Unanticipated device-related adverse events | before discharge, 7d, 14d, 1mo, 3mo, 6mo, 12mo, 24mo |
| Pregnancy (in women seeking to become pregnant) | 3mo, 6mo, 12mo, 24mo |
| Postoperative recovery | up to 28 days |
| Miscarriage | 1mo, 3mo, 6mo, 12mo, 24mo |
| Procedure related hospital readmission | 7d,14d, 1mo, 3mo, 6mo, 12mo, 24mo |
| Impact of covariates / Including length of pneumoperitoneum | before discharge, 7d,14d, 1mo, 3mo, 6mo, 12mo, 24mo |
| Menstrual Cycle | 1m, 3mo, 6mo, 12mo, 24mo |
Countries
Germany
Outcome results
None listed