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Completed

NCT Number: NCT04007211

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

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

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Key information

Conditions

Postoperative Adhesion of Uterus

Age range

19 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABT13107

Device

Dose: 3mL, maximum 10mL

Hyalobarrier

Device

Dose: 10mL

Primary outcomes

  1. Incidence of intrauterine adhesion

    Time frame: 4 weeks

    Incidence rate of intrauterine adhesion after surgery

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 5, 2019
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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