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A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding

NCT02842736 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2021-01-05

Study results available
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Summary

The purpose of the study is to evaluate the safety and effectiveness of the Cerene Cryotherapy Device in reducing menstrual bleeding in women with heavy menstrual bleeding (menorrhagia) due to benign causes for whom child bearing is complete.

Conditions

  • Menorrhagia

Interventions

DEVICE

Cerene(R) Cryotherapy Device

Sponsors & Collaborators

  • Channel Medsystems

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-04-30
Completion
2020-05-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Mexico

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 NCT02842736 on ClinicalTrials.gov