MedTrace Logo

Pilot Study of NASHA/Dx Gel for Fecal Incontinence

NCT00971269 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2009-09-03

No results posted yet for this study

Summary

The study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.

Conditions

  • Fecal Incontinence

Interventions

DEVICE

Solesta (Nasha/Dx)

Gel (hyaluronic acid/dextranomer) for intersphincteric injection 4x2 ml and retreatment 4x2 ml after 4 weeks

Sponsors & Collaborators

  • Uppsala University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-12-31
Completion
2011-06-30

Countries

  • Sweden

More Related Trials

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 NCT00971269 on ClinicalTrials.gov