Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Applied to Postoperative Intrauterine
NCT04007211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192
Last updated 2020-08-25
Summary
This study is intended to evaluate the efficacy and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine.
Conditions
- Postoperative Adhesion of Uterus
Interventions
- DEVICE
-
ABT13107
Dose: 3mL, maximum 10mL
- DEVICE
-
Hyalobarrier
Dose: 10mL
Sponsors & Collaborators
-
Medy-Tox
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-02-27
- Primary Completion
- 2018-08-29
- Completion
- 2018-08-29
Countries
- South Korea
Study Locations
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