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CompletedNCT04007211Updated Aug 25, 2020

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

An interventional study of ABT13107 and Hyalobarrier in Postoperative Adhesion of Uterus, sponsored by Medy-Tox. Completed at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-08-25.

Sponsored by Medy-Tox · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Feb 2017, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
19 Years to 70 Years
Sex
Female
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Study summary

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

02

Conditions studied

  • Postoperative Adhesion of Uterus

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03

In context

Tissue Adhesions

241 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.

This study's enrollment of 192 is above the median of 60 across 184 interventional studies indexed under Tissue Adhesions.

Browse Tissue Adhesions studies →

Lead sponsor

Medy-Tox is the lead sponsor of 48 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
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

Exclusion Criteria:

  • Those who will apply other intrauterine device rather than investigational device during the study period.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
192 participants (actual)

Study arms

  • Experimental
    ABT13107

    Device: ABT13107

  • Active comparator
    Hyalobarrier

    Device: Hyalobarrier

Interventions

  • DeviceABT13107

    Dose: 3mL, maximum 10mL

  • DeviceHyalobarrier

    Dose: 10mL

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What researchers measure

Primary outcomes

  1. Incidence of intrauterine adhesion

    Incidence rate of intrauterine adhesion after surgery

    Time frame: 4 weeks

07

Study locations

1 site
  • Asan Medical Center
    Seoul, Korea, Republic of
08

References and documents

Publications

  • Lee DY, Lee SR, Kim SK, Joo JK, Lee WS, Shin JH, Cho S, Park JC, Kim SH. A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial. Yonsei Med J. 2020 Oct;61(10):868-874. doi: 10.3349/ymj.2020.61.10.868. PubMed 32975061 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04007211
Lead sponsor
Medy-Tox
Responsible party
Sponsor
First posted
Jul 5, 2019
Start date
Feb 27, 2017
Primary completion
Aug 29, 2018
Completion
Aug 29, 2018
Last update
Aug 25, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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