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Clinical Trials/NCT02398578
NCT02398578TerminatedPhase 1

Cystoscopic Ablation Via RF Energy Clinical Trial

Amphora Medical, Inc.4 sites in 2 countries63 target enrollmentStarted: February 2015Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Terminated
Enrollment
63
Locations
4
Primary Endpoint
Device-related complications through 24 month follow-up
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Phase I/II study to assess the safety and performance of the Amphora OAB system for treatment of urgency and frequency with or without urge incontinence caused by an overactive bladder.

Detailed Description

The study will enroll subjects with symptomatic idiopathic overactive bladder (OAB).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Device-related complications through 24 month follow-up

Time Frame: 24 month

Secondary Outcomes

  • Procedural Success(During the study procedure)
  • Change from Baseline of Quality of Life Scores(4 weeks, 12 weeks, 6, 12, 18, and 24 months)
  • Device Technical Success(During the study procedure)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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Cystoscopic Ablation Via RF Energy... | Clinical Trial