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

Medy-Tox192 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

192

Conditions

Postoperative Adhesion of Uterus

Interventions

ABT13107DEVICE

Dose: 3mL, maximum 10mL

HyalobarrierDEVICE

Dose: 10mL

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Incidence of intrauterine adhesion

Incidence rate of intrauterine adhesion after surgery

Time frame: 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.