Clinical trials: Urological Surgeries
Hemostasis
Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery.
- Trial name
- NOBLE-Open (NCT03873168)
- Testing
- HEMOBLAST™ Bellows
- Where
- 9 sites in Austria, France and 1 more
- Volunteers
- 64 people
- Sponsor
- Biom'Up France SAS
Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures
A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices
This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (general, gynecological, urological, and…
- Conditions
- Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures, Adult Lower Gastrointestinal Procedures, Adult Gastric Procedures
- Trial name
- NCT05039021
- Testing
- HARMONIC 1100 Shears
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 265 people
- Sponsor
- Ethicon Endo-Surgery
Urinary Stress Incontinence
Efficacy and Safety of Duloxetine
The purpose of this study is to monitor the long term safety and efficacy of duloxetine in the treatment of severe pure genuine stress incontinence.
- Trial name
- NCT00190619
- Testing
- Duloxetine
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- Eli Lilly and Company
Stress Urinary Incontinence
Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in…
- Trial name
- CELLEBRATE (NCT03104517)
- Testing
- AMDC-USR (iltamiocel)
- Where
- 21 sites in United States, United Kingdom
- Volunteers
- 96 people
- Sponsor
- Cook MyoSite
Intraoperative Ureter Injury
Dose-escalation Study of a Contrast Agent for Delineation of Urological Anatomy in Minimally Invasive Surgery
The purpose of this clinical trial is to study the safety and efficacy of an investigational imaging agent for delineation/visualization of urologic anatomy in the setting of minimally invasive surgery.
- Trial name
- NCT03106038
- Testing
- Nerindocianine for Injection
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Li-Cor, Inc.
Stress Urinary Incontinence
Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
The main purpose of this registry is to collect observational, long-term safety and effectiveness data in subjects who have received at least one dose of iltamiocel as part of the CLBT clinical study.
- Trial name
- CLBT RGST (NCT06743620)
- Testing
- iltamiocel
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- Cook MyoSite
Hemorrhage
SURGICEL® Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding in Adult Subjects
This is a prospective, single arm, multicentre, multispecialty, post market, clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis (control bleeding) when conventional methods of control are impractical…
- Trial name
- NCT03762200
- Testing
- SURGICEL Powder
- Where
- 8 sites in Belgium, United Kingdom
- Volunteers
- 103 people
- Sponsor
- Ethicon, Inc.
Kidney Neoplasm, Nephrectomy
Evaluation of 'RUS NE' in Robot-Assisted Partial Nephrectomy: Efficacy, Safety, and Stability
This study is a retrospective and prospective comparative study evaluating the efficacy, safety, and stability of the surgical navigation system 'RUS NE' in robot-assisted partial nephrectomy.
- Conditions
- Kidney Neoplasm, Nephrectomy, Surgical Navigation Systems, Renal Mass
- Trial name
- HTK_002 (NCT06945640)
- Testing
- RUS NE
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- Hutom Corp
Cardiac Rhythm Disorders, Urological Disorders
Product Surveillance Registry
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products.
- Conditions
- Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders
- Trial name
- PSR (NCT01524276)
- Where
- 402 sites in United States, Argentina and 39 more
- Volunteers
- 100,000 people
- Sponsor
- Medtronic
Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery, Pediatric and Adult: Skin Closure (Dermal Sutures)
Prospective, International Monosyn® Quick - Non Interventional Study
The Monosyn® Quick non-interventional study (NIS) has been designed to implement an action within the framework of a proactive post-market surveillance system.
- Conditions
- Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery, Pediatric and Adult: Skin Closure (Dermal Sutures), Women: Episiotomy, Pediatric: Urological Interventions (Circumcision, Phimosis Etc.)
- Trial name
- PRIMOQ (NCT03355001)
- Testing
- Monosyn® Quick
- Where
- 3 sites in Germany
- Volunteers
- 153 people
- Sponsor
- Aesculap AG
Robotic Surgical Procedures in Pediatric Urology
Versius Paediatrics Study
This is prospective, multi-phase, single arm, multi-centre, multi-surgeon feasibility clinical trial to provide proof of concept and clinical evidence regarding the safety and efficacy of Versius (robotic surgery medical device)…
- Trial name
- NCT06539442
- Testing
- Versius Surgical System
- Where
- 3 sites in United Kingdom
- Volunteers
- 150 people
- Sponsor
- CMR Surgical Ltd
Urinary Incontinence, Stress
Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery
To study the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) for patients that have undergone prior prostate…
- Conditions
- Urinary Incontinence, Stress, Urination Disorders, Urologic Diseases
- Trial name
- NCT02291432
- Testing
- autologous muscle-derived cells (AMDC)
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- Cook MyoSite
Urinary Incontinence, Stress
Quality of Life After Tension Free Transvaginal Sling / Tape Operation With a Titanized Surgical Tape (TiLOOP® Tape)
Validation of a new Quality of Life (QoL) questionnaire in a population of patient gaining a TiLOOP® TAPE surgical mesh for stabilization of the urethra.
- Trial name
- NCT01358214
- Testing
- Questionnaire on Quality of Life.
- Where
- Germany
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- pfm medical gmbh
Hemostasis
Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in laparoscopic abdominal, gynecological, and urological surgery.
- Trial name
- NOBLE-Laparo (NCT03873181)
- Testing
- HEMOBLAST™ Bellows
- Where
- 8 sites in Austria, France and 1 more
- Volunteers
- 102 people
- Sponsor
- Biom'Up France SAS
Overactive Bladder, Urinary Urge Incontinence
A Sham-Controlled Study to Evaluate the Safety and Efficacy of a Smart, Self-Adjusting, Surgery-Free, Wearable Bladder Neuromodulation System for Overactive Bladder
This is a prospective, multi-center, sham-controlled study comparing the safety and effectiveness of the self-adjusting, surgery-free, wearable Active System to a Sham System on adult Subjects diagnosed with OAB.
- Conditions
- Overactive Bladder, Urinary Urge Incontinence, Urge Incontinence
- Trial name
- REDUCEOAB (NCT05381116)
- Testing
- Avation System
- Where
- 6 sites in United States
- Volunteers
- 125 people
- Sponsor
- Avation Medical, Inc.
Stress Urinary Incontinence (SUI)
Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence
The goal of this pivotal clinical trial is to evaluate the safety and effectiveness of the SUI-100 device for the treatment of mild-to-moderate stress urinary incontinence (SUI) in females aged 22-70 years.
- Trial name
- SaHARA (NCT06862648)
- Testing
- Acoustic Stimulation Therapy Device
- Where
- 9 sites in United States
- Volunteers
- 130 people
- Sponsor
- Acoustic Wave Cell Therapy, Inc.
Benign, Malignant Tumors or Other Soft Tissue Removal, Nephrectomy or Partial Nephrectomy With Parenchyma Removal
The CUSA Clarity Soft Tissue Removal Study
To investigate the clinical performance and surgeon preferences of the CUSA® Clarity Ultrasonic Surgical Aspirator System for soft tissue removal during surgical procedures.
- Trial name
- NCT04298268
- Testing
- CUSA Clarity Ultrasonic Surgical Aspirator System use
- Where
- 5 sites in Germany, Italy
- Volunteers
- 100 people
- Sponsor
- Integra LifeSciences Corporation
Pediatric Surgical Procedures, Adult Surgical Procedures
A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures
The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical…
- Conditions
- Pediatric Surgical Procedures, Adult Surgical Procedures, Adult Gynecological Procedures, Adult Urological Procedures
- Trial name
- NCT06608485
- Testing
- HARMONIC 700 Shears
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 173 people
- Sponsor
- Ethicon Endo-Surgery
Overactive Bladder, Urinary Frequency
FREEOAB Study for Overactive Bladder
This is a prospective, multicenter study that was conducted to evaluate the safety and efficacy of a novel, closed-loop, continuous-sensing wearable neuromodulation system for Overactive Bladder symptom control.
- Conditions
- Overactive Bladder, Urinary Frequency, Urinary Incontinence, Urge, Urinary Urgency
- Trial name
- NCT04547920
- Testing
- Wearable Bladder Modulation System
- Where
- 9 sites in United States
- Volunteers
- 96 people
- Sponsor
- Avation Medical, Inc.
Hysterectomy, Partial Nephrectomy
Robotic MIS With Dexter
The purpose of this study is to confirm the perioperative and early postoperative safety and clinical performance of the Dexter Robotic System (Dexter Surgical System, Model DM-L6).
- Conditions
- Hysterectomy, Partial Nephrectomy, Right Colectomy
- Trial name
- NCT05537727
- Testing
- robotic-assisted surgery
- Where
- 5 sites in France, Germany and 1 more
- Volunteers
- 100 people
- Sponsor
- Distalmotion SA