Status:
COMPLETED
The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions
Lead Sponsor:
SciVision Biotech Inc.
Collaborating Sponsors:
Taipei Veterans General Hospital, Taiwan
Conditions:
Tissue Adhesion
Gynecologic Surgery
Eligibility:
FEMALE
20-65 years
Phase:
NA
Brief Summary
The aim of this study is to assess the safety and effectiveness of PROTAHERE Absorbable Adhesion Barrier to prevent pelvic postoperative adhesions.
Detailed Description
The study is a random, evaluator-blinded, controlled, single center clinical trial. Recruiting patients who are premenopausal and scheduled for pelvic surgery including myomectomy, pelvic adhenolysis,...
Eligibility Criteria
Inclusion
- Patients who are premenopausal.
- Patients who are scheduled for pelvic surgery including myomectomy, pelvic adhenolysis, endometriosis surgery, salpingostomy, dermoid cyst removal, ovarian cystectomy or any pelvic surgery other than total metrectomy.
- Patients who are 20 years old or older.
- Patients who are able to understand the objectives, sign the informed consent form, and willing to comply with study procedures.
Exclusion
- Patients who are 65 years old or older.
- Presence of uncontrolled diabetes, coagulative disorders, severe urinary system infection, or other severe diseases.
- Presence of malignant tumor or diagnosed with cancer.
- Any physical or psychological illness or symptom which is considered unsuitable to enroll by physicians.
- Patients who are unwilling to comply with study procedures.
- Patients who are known to have hypersensitivity to hyaluronic acid implants.
Key Trial Info
Start Date :
April 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2023
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT04063085
Start Date
April 25 2018
End Date
October 12 2023
Last Update
April 17 2024
Active Locations (1)
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1
Taipei Veterans General Hospital
Taipei, Taiwan