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Study to Assess the Safety and Efficacy of the IUB SEAD™ Device

NCT04381416 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-11-08

No results posted yet for this study

Summary

Pre-pivotal, randomized study to assess the safety and efficacy of the IUB SEAD™ device in women suffering from abnormal uterine bleeding.

Conditions

  • Abnormal Uterine Bleeding

Interventions

DEVICE

SEAD treatment

up to two 30-min endometrial ablation sessions using the IUB SEAD™ device, in a hospital outpatient clinic

Sponsors & Collaborators

  • Ocon Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Rouemen Velev, Md · Sheynovo medical center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-06-30
Completion
2022-12-31

Countries

  • Bulgaria

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 NCT04381416 on ClinicalTrials.gov