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Safety of Leaving Cook Balloon Uterine Stent in Uterus for One Month

NCT01167296 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-06-10

No results posted yet for this study

Summary

To use Cook balloon uterine stent to prevent intrauterine adhesion (IUA), and to see if leaving it in the uterus will cause uterine infection.

Conditions

  • Intrauterine Adhesion

Interventions

DEVICE

Cook balloon uterine stent

Immediately before hysteroscopic surgery, a culture tip is inserted into the uterine cavity and sent for culture. Another culture was done 30 days later, and a second-look hysteroscope is done to evaluate the healing of uterine cavity.

Sponsors & Collaborators

  • Shin Kong Wu Ho-Su Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-07-31
Completion
2011-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01167296 on ClinicalTrials.gov