Postoperative Adhesion of Uterus Clinical Trial
Official title:
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
| Verified date | August 2020 |
| Source | Medy-Tox |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is intended to evaluate the efficacy and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine.
| Status | Completed |
| Enrollment | 192 |
| Est. completion date | August 29, 2018 |
| Est. primary completion date | August 29, 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 19 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Female patients aged from 19 to 70 - Those who are scheduled for hysteroscopy to treat the following diseases: submucosal myomas, endometrial polyps, intrauterine adhesion etc. Exclusion Criteria: - Those who will apply other intrauterine device rather than investigational device during the study period. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Asan Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Medy-Tox |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of intrauterine adhesion | Incidence rate of intrauterine adhesion after surgery | 4 weeks |