Clinical trials: Fecal Incontinence
Urinary Incontinence, Fecal Incontinence
Incontinence Management System ICU Field Evaluation
The objective of this Field Evaluation is to assess usage and satisfaction associated with the Hill-Rom Incontinence Management System.
- Trial name
- NCT03628833
- Testing
- Incontinence Management System
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Hill-Rom
Fecal Incontinence
Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.
- Trial name
- NCT05708612
- Testing
- Medical Device (SimplyFI)
- Where
- 5 sites in Austria, Germany and 1 more
- Volunteers
- 36 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Fecal Incontinence (FI)
Safety and Feasibility Evaluation of ALVIV Laser Based Treatment for Fecal Incontinence
The purpose if this interventional First in Human study is to assess the Safety and Performance of the ALVIV System laser based treatment in patients diagnosed with Fecal Incontinence.
- Trial name
- NCT07436676
- Testing
- ALVIV Laser Treatment
- Where
- Israel
- Volunteers
- 12 people
- Sponsor
- Alviv Ltd.
Fecal Incontinence
Pursuit: Real World Use of the Eclipse System
A prospective, open label post-market registry to collect Patient Reported Outcomes and Fitting metrics (e.g. sizes used) in subjects using the Eclipse System in a commercial setting.
- Trial name
- PURSUIT (NCT03940573)
- Testing
- Eclipse Insert
- Where
- 6 sites in United States
- Volunteers
- 150 people
- Sponsor
- Pelvalon, Inc.
Fecal Incontinence
A Feasibility Study of a Fecal Incontinence Management System for Medical Use
The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System.
- Trial name
- NCT00556972
- Testing
- Fecal Incontinence Management System
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Coloplast A/S
Fecal Incontinence
A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)
The objective of this study is to obtain preliminary efficacy and safety data on the use of the LivSure System (now called the "Eclipse™ System") in women with fecal incontinence.
- Trial name
- LIFE (NCT01655498)
- Testing
- vaginal bowel control system (LivSure)
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Pelvalon, Inc.
Fecal Incontinenece
A Double Blinded Study to Examine the Effect of Coated Suppositories on Fecal Incontinence in Patients With Spinal Cord Injury
This is a double blinded cross over study. Approximately 20 spinal cord injury patients will be participating in this 4 weeks study.The primary outcome is difference in fecal incontinence as recorded in diaries, between the…
- Trial name
- NCT01297608
- Testing
- caoted suppository, coated suppository
- Where
- Israel
- Sponsor
- RDD Pharma Ltd
Fecal Incontinence and Constipation
Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation
- Trial name
- MDT-301 (NCT00200005)
- Testing
- Type: Implantable neurostimulator; InterStim
- Where
- 9 sites in United States, Austria and 6 more
- Volunteers
- 140 people
- Sponsor
- MedtronicNeuro
Fecal Incontinence
Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers
This study is conducted to explore the safety and tolerability and plasma pharmacokinetics of NRL001 after single intra-anal dose of 1mL cream at increasing concentrations.
- Trial name
- NCT01406925
- Testing
- NRL001 cream
- Where
- Bulgaria
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Norgine
Fecal Incontinence
An Study to Examine the Effect of Coated Suppositories on Anal Pressure in Healthy Subjects
This is an open label, dose-finding, 2-parts study. Approximately 6 subjects will be participating in this study. This study is composed of 2 parts: Part 1 is a dose finding study.
- Trial name
- NCT01265485
- Testing
- coated suppository
- Where
- Israel
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- RDD Pharma Ltd
Fecal Incontinence
Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)
The purpose of this observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting.
- Trial name
- SoFI (NCT01647906)
- Where
- 20 sites in United States
- Volunteers
- 277 people
- Sponsor
- Bausch Health Americas, Inc.
Fecal Incontinence
A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence
The purpose of this study is to evaluate a new injectable bulking agent for the treatment of fecal incontinence in adult men and women.
- Trial name
- NCT00762047
- Testing
- Durasphere FI
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Carbon Medical Technologies
Fecal Incontinence
Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence
This is first-in-human prospective Phase I study of the immediate and long-term safety of an implanted internal anal sphincter (IAS) bioengineered from autologous cells to treat subjects with severe passive FI who have failed…
- Trial name
- NCT05616208
- Testing
- Bioengineered Internal Anal Sphincter
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cellf Bio LLC
Fecal Incontinence
A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence
The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence.
- Trial name
- NCT00605826
- Testing
- NASHA/Dx (Solesta) Gel
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 206 people
- Sponsor
- Bausch Health Americas, Inc.
Fecal Incontinence
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
- Trial name
- NCT07499258
- Testing
- Axonics SNM System INS Model 5101 (R20)
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 55 people
- Sponsor
- Axonics, Inc.
Complex Anal Fistulas
Fistura® Procedure for the Treatment of Complex Anal Fistulas
This study aims to evaluate the healing rate of complex fistulas using radiofrequency (Fistura® procedure), in a prospective, interventional, monocenter, single-arm design.
- Trial name
- NCT06113068
- Testing
- Fistura® procedure
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- F Care Systems NV
Fecal Incontinence
Safety, Tolerability, Pharmacodynamic and Pharmacokinetics of a Single Rectal Application of 10 mg NRL001 in Elderly Subjects
A total of 26 healthy elderly male and female subjects will receive both 10 mg NRL001 in a 2 g rectal suppository and placebo in this double-blind, cross-over study.
- Trial name
- NCT01099683
- Testing
- NRL001
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Norgine
Fecal Incontinence, Bowel Dysfunction
LIBERATE - PRO: Eclipse™ System Registry
A prospective, open label post market registry to collect Patient Reported Outcomes in an online data capture registry, maintained by Pelvalon, of women with fecal incontinence exiting the LIBERATE study (NCT02428595) continuing…
- Conditions
- Fecal Incontinence, Bowel Dysfunction, Bowel Incontinence, Accidental Bowel Leakage
- Trial name
- LIBERATEPRO (NCT03028636)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Pelvalon, Inc.
Faecal Incontinence, Constipation - Functional
Peristeen Light Explorative Clinical Investigation
The goal of this exploratory clinical investigation is to understand the clinical benefits of Peristeen Light in adult patients with faecal incontinence, chronic constipation and/or time-consuming bowel management procedures.
- Trial name
- NCT07126327
- Testing
- Peristeen Light - trans anal irrigation system
- Where
- 2 sites in Denmark, Italy
- Volunteers
- 60 people
- Sponsor
- Coloplast A/S
Fecal Incontinence
Autologous Cell Therapy for Treatment of Fecal Incontinence
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment…
- Trial name
- NCT01600755
- Testing
- Iltamiocel
- Where
- 2 sites in Canada, United Kingdom
- Volunteers
- 53 people
- Sponsor
- Cook MyoSite