NCT04638855

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2011

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

November 16, 2020

Last Update Submit

September 28, 2021

Conditions

Intrauterine SynechiaeTissue Adhesion, Surgery-Induced

Keywords

MedicurtainSodium hyaluronateAnti-adhesion barrier

Outcome Measures

Primary Outcomes (1)

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

    Adhesion rate: {(number of subjects occurred adhesion formation for each group)/ (number of subjects for each group)} \* 100

    4 weeks

Secondary Outcomes (4)

  • Comparison of Adhesion Grade between treated group and untreated control group

    4 weeks

  • The incidence rate of adverse events

    follow up to 4 weeks

  • The incidence rate of adverse drug reaction

    follow up to 4 weeks

  • The incidence rate of serious adverse events

    follow up to 4 weeks

Study Arms (2)

Medicurtain®

EXPERIMENTAL

Treat Medicurtain 5ml prefilled syringe after hysteroscopy surgery

Device: Medicurtain®

Placebo

SHAM COMPARATOR

No device after hysteroscopy surgery

Device: Placebo

Interventions

Medicurtain®DEVICE

Anti-adhesion barrier (Medicurtain® 5ml prefilled syringe after hysteroscopy surgery)

Medicurtain®
PlaceboDEVICE

No device after hysteroscopy surgery

Placebo

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Woman who is between 20\~80 years of age.
  • Woman who is reserved elective hysteroscopy for
  • Uterine polyp
  • Uterine (endometrium) myoma
  • Missed miscarriage (uterine lesion suspected to be associated with pregnancy)
  • Adhesion in uterine
  • Woman who signed an informed consent form prior to the investigation.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

GynatresiaTissue Adhesions

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Byeongseok Lee, MD

    Gangnam Severance Hospital, 712 Eonju-ro, Gangnam, Seoul, South Korea

    PRINCIPAL INVESTIGATOR

  • Youngsik Choi, MD

    Severance Hospital, 134 Sinchon-dong, Seodaemun-gu, Seoul, South Korea

    PRINCIPAL INVESTIGATOR

  • Sun Hee Cha, MD

    Bundang CHA Medical Center, 351 Yatap-dong, Seongnam-si, Gyeonggi-do, South Korea

    PRINCIPAL INVESTIGATOR

  • Joomyung Kim, MD

    CHEIL General Hospital & Women's Healthcare Center, 1-19 Mukjeong-dong, Jung-gu, Seoul, South Korea

    PRINCIPAL INVESTIGATOR

  • Ki-Hwan Lee, MD

    Chungnam National University Hospital, 33 Munhwa-ro, Jung-gu, Daejeon, South Korea

    PRINCIPAL INVESTIGATOR

  • In Taek Hwang, MD

    Daejeon Eulji Medical Center, Dunsan-2-dong, Seo-gu, Daejeon, South Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Evaluator-blinded
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Pivotal study (Determine effectiveness and adverse effects)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 20, 2020

Study Start

September 8, 2010

Primary Completion

December 3, 2011

Study Completion

December 3, 2011

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)