Clinical study on tissue adhesion preventive devices Trehalose based novel devices for postoperative tissue adhesions

UMIN ID: UMIN000000768

Registered date:16/07/2007

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Uterine leiomyoma, ovarian tumor, tubal adhesion, caesarotomy
• Date of first enrollment: 2007/07/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Trehalose-based tissue adhesion preventive device is sprayed over the whole operative field or abdominal cavity during laparoscopical or open abdominal surgery due to uterine leiomyoma, ovarian tumor or tubal adhesion, or during caesarotomy.

Outcome(s)

• Primary Outcome: Confirmation of safety and efficacy of trehalose-based tissue adhesion preventive devices

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Female
• Exclude criteria: 1 Pregnant women, except for cesarean section patients 2 Patients who have received intravenous drip injections and, or perfusates containing dextran, heparin, corticosteroids or nonsteroidal antiinflammatory drugs. 3 Patients who chronically need to receive corticosteroids, or patients who are administered corticosteroids and, or nonsteroidal antiinflammatory drugs within 24 hours prior to surgeries. 4 Patients who have been treated with Interseeds or PRECLUDE surgical membranes or have received other antiadhesion treatments. 5 Patients in the physical conditions that can affect evaluation of safety and efficacy of the present device or Seprafilm. 6 Patients with histories of severe drug allergies. 7 Patients who have received other research products that might affect evaluations of safety and efficacy of the present device during the trial period. 8 Patients with active pelvic inflammatory diseases or peritonitis. 9 Patients who have had open abdominal operations. 10 Patients whose SGOT, SGPT or bilirubin level is more than 20 percent higher than each upper limit. 11 Patients whose BUN and creatinine level are more than 30 percent higher than each upper limit. 12 Patients with severe diabetes mellitus with over 8 percent of HbA1c. 13 Patients who are judged to be inappropriate for the study by doctors in their charge

Related Information

• Primary Sponsor: The University of Tokyo Hospital Department of Obstetrics & Gynecology
• Source(s) of Monetary Support: NEXT21 K.K.