CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 153 enrolled
Drug / intervention
Ajust Adjustable Single-Incision Slingdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01290796
NCT01290796N/ACompleted
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Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (CEASe)

C. R. Bard·interventional·Posted Feb 7, 2011·Updated Mar 27, 2017

In Brief

A clinical study evaluating Ajust Adjustable Single-Incision Sling for Female Stress Urinary Incontinence. Completed, enrolled 153 participants across 6 sites.

Detailed Summary

The purpose of this study is to assess the overall effectiveness of the Ajust Adjustable Single-Incision Sling in the surgical treatment of female stress urinary incontinence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFemale Stress Urinary Incontinence
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 7, 2011
Enrollment StartJan 1, 2011
Primary CompletionJun 1, 2013
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.4 years ago

Interventions

Ajust Adjustable Single-Incision Slingdevice

The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.