Trials / Completed
CompletedNCT04007211
Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Applied to Postoperative Intrauterine
A Randomized, Multi-center, Evaluator and Subject Blind, Active-controlled, Parallel, Medical Device Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Compared to Hyalobarrier Applied to Postoperative Intrauterine
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 192 (actual)
- Sponsor
- Medy-Tox · Industry
- Sex
- Female
- Age
- 19 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study is intended to evaluate the efficacy and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ABT13107 | Dose: 3mL, maximum 10mL |
| DEVICE | Hyalobarrier | Dose: 10mL |
Timeline
- Start date
- 2017-02-27
- Primary completion
- 2018-08-29
- Completion
- 2018-08-29
- First posted
- 2019-07-05
- Last updated
- 2020-08-25
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04007211. Inclusion in this directory is not an endorsement.