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

Medytox

Status: Completed

Conditions: Postoperative Adhesion of Uterus

Treatments: Device: ABT13107; Device: Hyalobarrier

Study type: Interventional

Funder types: Industry

Identifiers

NCT04007211

MT10-KR16IUA705

Details and patient eligibility

About

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

Enrollment: 192 patients

Sex: Female

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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192 participants in 2 patient groups

ABT13107

Experimental group

Treatment:

Device: ABT13107

Hyalobarrier

Active Comparator group

Treatment:

Device: Hyalobarrier