Back to resultsPivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Applied to Postoperative Intrauterine
Primary Purpose
Postoperative Adhesion of Uterus
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ABT13107
Hyalobarrier
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Adhesion of Uterus
Eligibility Criteria
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.
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ABT13107
Hyalobarrier
Arm Description
Outcomes
Primary Outcome Measures
Incidence of intrauterine adhesion
Incidence rate of intrauterine adhesion after surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04007211
Brief Title
Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Applied to Postoperative Intrauterine
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
August 29, 2018 (Actual)
Study Completion Date
August 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medy-Tox
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is intended to evaluate the efficacy and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Adhesion of Uterus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABT13107
Arm Type
Experimental
Arm Title
Hyalobarrier
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
ABT13107
Intervention Description
Dose: 3mL, maximum 10mL
Intervention Type
Device
Intervention Name(s)
Hyalobarrier
Intervention Description
Dose: 10mL
Primary Outcome Measure Information:
Title
Incidence of intrauterine adhesion
Description
Incidence rate of intrauterine adhesion after surgery
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
32975061
Citation
Lee DY, Lee SR, Kim SK, Joo JK, Lee WS, Shin JH, Cho S, Park JC, Kim SH. A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial. Yonsei Med J. 2020 Oct;61(10):868-874. doi: 10.3349/ymj.2020.61.10.868.
Results Reference
derived
Learn more about this trial
Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Applied to Postoperative Intrauterine
We'll reach out to this number within 24 hrs