primary removal of myomas in women
Conditions
Interventions
implanation of ADBLOCK gel
surgery only
Sponsors
Terumo Europe N.V.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: i)Female ii)18-45 years iii)Indication for laparoscopic myomectomy according to the medical standard iv)Negative pregnancy test before study entry v)Using adequate forms of contraception for 12 weeks following surgery (e.g. oral contraceptive pill, condom, no sexual intercourse) vi)In good health including an ASA (American Society of Anesthesiologists) score of 2 or less vii)No clinically significant and relevant abnormalities as evaluated by satisfactory medical assessment viii)Planned de novo removal of myoma (includes mural and combination of mural and pedunculated myoma) ix)Willing, able and likely to fully comply with study procedures and restrictions x)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
Exclusion criteria: Pre-Operative Exclusion Criteria: i)Women who have completed their family planning ii)Current pregnancy including ectopic pregnancy iii)Breastfeeding iv)6 weeks post-partum v)Participation in another clinical study currently or within the last 30 days prior to enrolment vi)SGOT, SGPT and/or bilirubin >20% above the upper range of normal and considered clinically significant vii)BUN and creatinine >30% above the upper range of normal and considered clinically significant viii)Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation ix)Previous radiation therapy x)Diabetes xi)Clinically relevant haemochromatosis, hepatic, renal, autoimmune, lymphatic, haematological or coagulation disorders xii)Active pelvic or abdominal infection, or other infection with fever xiii)Extensive keloid scarring xiv)Known allergy to starch-based polymers xv)Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of the stated ingredients xvi)Additional surgical procedure non-obstetrics and gynaecology (non- OB/GYN) planned to be performed during the laparoscopic procedure xvii)4 myoma larger than 2 cms on preoperative ultrasound screen xviii)Largest myoma <2 cms or >8 cms diameter on pre-operative screen xix)GNRH agonist/antagonist treatment (except oral contraceptive; combined oestrogen/progesterone) in the 4 weeks prior to study xx)Prior surgery for myoma xxi)Prevoius bowl surgery, excluding appendectomy xxii)Prior intra-abdominopelvic adhesive complications Intraoperative Exclusion Criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety as evaluated by assessment of adverse events in ADBLOCK and surgery only group up to 28 days | — |
Countries
Europe
Contacts
Public ContactKazuhisa SENSHU
Terumo Europe N.V. European Medical and clinical div
Outcome results
None listed