Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Applied to Postoperative Intrauterine

• Sponsor: Medy-Tox (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04007211
• Collaborator: (none)
• Enrollment: 192
• Location: 1
• Arms: 2
• Actual Duration (Months): 18
• Patients Per Site Per Month: 10.7

Study Details

Study Description

Brief Summary

This study is intended to evaluate the efficacy and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Adhesion of Uterus	Device: ABT13107; Device: Hyalobarrier	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 27, 2017
• Actual Primary Completion Date: Aug 29, 2018
• Actual Study Completion Date: Aug 29, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABT13107	Device: ABT13107; Dose: 3mL, maximum 10mL
Active Comparator: Hyalobarrier	Device: Hyalobarrier; Dose: 10mL

Outcome Measures

Primary Outcome Measures

1. Incidence of intrauterine adhesion [4 weeks]

   Incidence rate of intrauterine adhesion after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Medy-Tox

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medy-Tox
• ClinicalTrials.gov Identifier: NCT04007211
• Other Study ID Numbers: MT10-KR16IUA705
• First Posted: Jul 5, 2019
• Last Update Posted: Aug 25, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tissue Adhesions

Study Results

No Results Posted as of Aug 25, 2020