Safety confirmation study with dMD-003
Phase 2
- Conditions
- terine leiomyoma
- Registration Number
- JPRN-jRCT2072230083
- Lead Sponsor
- Aihara Fumiaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
(1) Patients scheduled to undergo laparoscopic, laparoscopy-assisted, or open uterine myomectomy.
Other criteria.
Exclusion Criteria
(1) Patients who have undergone surgery in the abdominal or pelvic cavity (excluding surgery for appendicitis).
(2) Patients with concurrent active pelvic inflammatory disease or peritonitis.
(3) Patients suspected of having moderate (stage III) or severe endometriosis according to the r-ASRM classification.
Other criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events up to 12 weeks after surgery.
- Secondary Outcome Measures
Name Time Method