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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04007211

Enrollment

192

Registered

2019-07-05

Start date

2017-02-27

Completion date

2018-08-29

Last updated

2020-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Adhesion of Uterus

Brief summary

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

Interventions

DEVICEABT13107

Dose: 3mL, maximum 10mL

DEVICEHyalobarrier

Dose: 10mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of intrauterine adhesion	4 weeks	Incidence rate of intrauterine adhesion after surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026