CompletedNot Applicable

The Efficacy and Safety of Medicurtain® in Patients With Hysteroscopy (Pivotal Study)

South Korea223 participantsStarted 2010-09-08

Plain-language summary

This study was designed to assess the safety and efficacy of MEDICURTAIN, an adhesion barrier in patients who underwent hysteroscopy with uterine polyp or endometrial myoma or missed abortion (uterine lesion suspected to be associated with pregnancy) or intrauterine adhesion. Adhesion formation in both groups was evaluated by the grading scale and photographs taken during the follow up to evaluate the safety and efficacy of the product.

Who can participate

Age range20 Years – 60 Years

SexFEMALE

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Inclusion criteria

✓. Woman who is between 20\~80 years of age.
✓. Woman who is reserved elective hysteroscopy for
✓. Woman who signed an informed consent form prior to the investigation.

Exclusion criteria

✕. Presence of tumor or inflammatory disease in other organs.
✕. Subject who is not eligible for anesthesia or re-operation due to other disease confirmed by investigator.
✕. Subject who is not eligible for re-operation or hysteroscopy
✕. Any condition which made a subject unsuitable for inclusion in the discretion of the Investigator will be excluded.

What they're measuring

Outcome Measure: comparison between treated group and untreated control group for the adhesion rate

Timeframe: 4 weeks

Trial details

NCT IDNCT04638855

SponsorShin Poong Pharmaceutical Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-12-03

View on ClinicalTrials.gov More Intrauterine Synechiae trials