Status:
UNKNOWN
A Safety and Effectiveness Study of DividPro Film in Open Abdominal Surgery
Lead Sponsor:
Industrial Technology Research Institute, Taiwan
Conditions:
Open Abdominal Surgery
Abdominal Adhesion
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
Abdominal adhesions frequently occur after surgery and may be one of the main reasons to cause discomfort, pain and related bowel movement symptoms. The goal of this clinical trial is to evaluate the ...
Detailed Description
Adhesion may occur due to the excessive production of fibrous tissue during the process of wound healing. Abdominal adhesion could play a role on intestine obstruction which will lead to lack of blood...
Eligibility Criteria
Inclusion
- Written informed consent before any study specific procedure is performed.
- Ages of 20-70 years old on the day of consent.
- Subject who is diagnosed with a liver, gallbladder, pancreas and upper/lower gastrointestinal disorder.
- Subject who is scheduled to accept an open abdominal operation involving liver, gallbladder, pancreas, stomach, spleen, intestine or female pelvic organ.
- The Investigational product can be implanted appropriately between the surgical wound and operated organ and is able to cover the entire wound area.
Exclusion
- Subject who is hypersensitive to the ingredient of DividPro film \[Poly (DL-lactide)\]
- Subject who is concurrently participating in another clinical trial with a drug or a device.
- Subject who has taken Immunosuppressive drugs/agents long-term or taken NSAIDs within 7 days before trial's operation.
- Subject who has participated in a clinical trial with a drug or a device within 30 days prior to this study.
- Subject who has received or is expected to receive any other product or technique belonging to the group of adhesion reduction devices or other products, meshes, or other types of implants in the abdominal cavity within 30 days prior to or during enrollment.
- Subject who has had hernia mesh placed under the abdominal wall.
- Subject with peritonitis.
- Subject with hematological, neurological or immune critical illness.
- Subject who has malnutrition, uncontrolled diabetes or any other conditions that the investigator considers might not be suitable for enrollment to the study.
- Subject with other potential infections.
- Subject with BMI≧40.
- Female subject who is lactating or pregnant.
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06142526
Start Date
December 12 2023
End Date
December 1 2025
Last Update
December 18 2023
Active Locations (1)
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1
National Taiwan University Cancer Center
Taipei, Taiwan, 106