Clinical trials: Sacral Disorder
Urinary Incontinence, Urge
CAN-Stim Compared to SNS in Treatment of Urinary Urgency Incontinence With Wireless Neuromodulation Technology
This is a prospective, randomized, controlled, multi-center, study in which 150 evaluable subjects will be randomized 1:1 to receive either a Protect CAN-Stim or SNS InterStim® system.
- Trial name
- PROTECT (NCT02577302)
- Testing
- CAN-Stim - Protect CAN-Stim System, SNS - InterStim® System
- Where
- 15 sites in United States
- Volunteers
- 200 people
- Sponsor
- Uro Medical Corporation
Spondylolisthesis
Posterior Lateral Fusion (PLF) With Dynesys
The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System.
- Trial name
- NCT00791180
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Zimmer Biomet
Pelvic Organ Prolapse, Cystocele
Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair
Compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems.
- Trial name
- NCT02258230
- Testing
- 3D mode of the 3D Laparoscopic Video System, 2D mode of the 3D Laparoscopic Video System
- Where
- 2 sites in United States
- Volunteers
- 194 people
- Sponsor
- Olympus Corporation of the Americas
Overactive Bladder, Urinary Urgency Incontinence
Sacral Neuromodulation for Male Overactive Bladder (MOAB)
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
- Conditions
- Overactive Bladder, Urinary Urgency Incontinence, Benign Prostatic Hyperplasia, Prostate Cancer
- Trial name
- NCT06511141
- Testing
- Axonics SNM System
- Where
- 23 sites in United States
- Volunteers
- 150 people
- Sponsor
- Axonics, Inc.
Ulcerative Colitis, Inflammatory Bowel Diseases
BOOM-IBD2 Pivotal Clinical Trial
Ulcerative colitis is a long-lasting condition that causes swelling and sores in the large intestine. This study tests whether a small device placed under the skin can help reduce bowel urgency in people with ulcerative colitis.
- Trial name
- NCT06571669
- Testing
- Neuromodulation
- Where
- 19 sites in United States
- Volunteers
- 137 people
- Sponsor
- Boomerang Medical
Urinary Retention, Urinary Urge Incontinence
Axonics SacRal NeuromodulaTIon System RegisTRY Study
To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).
- Conditions
- Urinary Retention, Urinary Urge Incontinence, Urgency-Frequency, Fecal Incontinence
- Trial name
- ARTISTRY (NCT05064384)
- Where
- 27 sites in United States, Canada
- Volunteers
- 272 people
- Sponsor
- Axonics, Inc.
Fecal Incontinence
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel movement) in order to expel it at a proper time and place.
- Trial name
- NCT00200057
- Testing
- InterStim Sacral Nerve Stimulation Therapy
- Where
- 13 sites in United States, Canada
- Volunteers
- 285 people, healthy volunteers welcome
- Sponsor
- MedtronicNeuro
Urinary Incontinence, Urge
Sacral Nerve Stimulation to Treat Urgency Urinary Incontinence With Wireless Neuromodulation
The purpose of this pivotal study is to illustrate the safety and effectiveness of the StimGuard Sacral Nerve Stimulation (SNS) System in the treatment refractory urge incontinence.
- Trial name
- NCT02434874
- Testing
- StimGuard Sacral Nerve Stimulator System
- Where
- United States
- Sponsor
- Uro Medical Corporation
Urinary Urge Incontinence
Neuspera Revision Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics
Single-arm study where subjects' responses to a questionnaire for the traditional Sacral Neuromodulation (SNM) devices will be compared to the responses regarding the Neuspera SNM System.
- Trial name
- NCT07383688
- Testing
- Neuspera Implantable Sacral Neuromodulation System
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Neuspera Medical, Inc.
Pressure Ulcers (Hospital-acquired Pressure Injuries)
Sacrum Pressure Injury Prevention Study Using ALLEVYN◊ Complete Care in Adults at Risk of Developing Hospital-acquired Pressure Injuries in Critical Care Units
The purpose of this study is to investigate the use of ALLEVYN◊ COMPLETE CARE Sacrum dressing for the prevention of hospital-acquired pressure injuries in adults.
- Trial name
- PACCT (NCT07849387)
- Testing
- ALLEVYN◊ COMPLETE CARE Sacrum
- Where
- 3 sites in United States
- Volunteers
- 330 people
- Sponsor
- Smith & Nephew, 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.
Sacroiliitis
Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
The Neurolyser XR is a device used to deliver high-intensity focused ultrasound for the ablation of the lateral sacral branch nerve in patients with Sacroiliitis.
- Trial name
- NCT06053255
- Testing
- High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- FUSMobile Inc.
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
Refractory Overactive Bladder
A Study to Compare the Efficacy and Safety of Ultrasound Guided Lead Implantation for Sacral Neuromodulation (SNM) in Subjects With Overactive Bladder (OAB) With X-Ray Guided Technique
Overactive bladder(OAB,Urgency) was determined by International Continence Society as Urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract…
- Trial name
- NCT02946723
- Testing
- ultrasound, X-ray
- Volunteers
- 30 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Urinary Urge Incontinence
InterStim® Sacral Nerve Modulation Cycling Study
The study will assess the effects of different InterStim cycling settings on urinary urge incontinence.
- Trial name
- NCT01957137
- Testing
- InterStim® (Device Programming)
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- MedtronicNeuro
Overactive Bladder
Treatment of REfractory Overactive BLadder With the AXonics Sacral Neuromodulation System (RELAX-OAB)
The RELAX-OAB (Treatment of REfractory Overactive BLadder with the AXonics Sacral Neuromodulation System) is a post-market clinical follow-up (PMCF) study designed to confirm the performance of the Axonics Sacral Neuromodulation…
- Trial name
- RELAX-OAB (NCT02620410)
- Testing
- Axonics Sacral Neuromodulation (SNM) System
- Where
- 6 sites in Belgium, France and 2 more
- Volunteers
- 51 people
- Sponsor
- Axonics, Inc.
Urinary Incontinence, Over Active Bladder
Sacral Neuromodulation With InterStim® Therapy for Intractable Urinary Voiding Dysfunctions (SOUNDS): an Observational Study
The purpose of this study is to document the safety, the effectiveness, the continued performance at mid and long term, the morbidity and the percent of surgical revisions of the Interstim® therapy for up to 5 years in a…
- Conditions
- Urinary Incontinence, Over Active Bladder, Urinary Retention
- Trial name
- SOUNDS (NCT02186041)
- Testing
- Sacral Nerve Modulation
- Where
- 24 sites in France
- Volunteers
- 320 people
- Sponsor
- MedtronicNeuro
Urinary Incontinence, Urge
Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt
The ARTISAN-SNM study is designed to evaluate the safety and effectiveness of the Axonics Sacral Neuromodulation System as an aid in the treatment of the symptoms of urinary urgency incontinence (UUI) in patients who have failed…
- Trial name
- ARTISAN-SNM (NCT03327948)
- Testing
- Axonics Sacral Neuromodulation System (SNM) System
- Where
- 4 sites in United States, Netherlands and 1 more
- Volunteers
- 129 people
- Sponsor
- Axonics, Inc.
Breast Cancer, Head and Neck Cancer
A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
This study evaluated the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study was conducted in patients with several types of refractory cancers including those at the surface of the…
- Conditions
- Breast Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, Lymphoma
- Trial name
- IT-01 (NCT03058289)
- Testing
- INT230-6, anti-PD-1 antibody, anti-CTLA-4 antibody
- Where
- 8 sites in United States, Canada
- Volunteers
- 111 people
- Sponsor
- Intensity Therapeutics, Inc.
Fecal Incontinence
French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence
The aim of this observational study is to evaluate the utilization in the clinical practice, effectiveness, explantation and re-intervention rate, complications and adverse events of InterStim system in patients indicated to…
- Trial name
- NCT01957969
- Testing
- Sacral Nerve Stimulation
- Where
- 16 sites in France
- Volunteers
- 234 people
- Sponsor
- MedtronicNeuro