Clinical trials: Cooking
Anorectal Fistula
Retrospective Review of the Cook Biodesign® Fistula Plug to Treat Anorectal Fistulas
The study is a retrospective review of the use of the Biodesign® Fistula Plug (C-FPS-[X]). A total of 73 patients will be enrolled who have had a fistula plug placed to treat anorectal fistulas and will therefore be eligible for…
- Trial name
- NCT03321266
- Testing
- Cook Biodesign® Fistula Plug
- Where
- 4 sites in United States, Germany
- Volunteers
- 79 people
- Sponsor
- Cook Group Incorporated
Colonic Obstruction, Colonic Stricture
Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System
The objective of this registry is to compile clinical data on the use of the Evolution® Colonic Stent System for the palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute…
- Conditions
- Colonic Obstruction, Colonic Stricture, Large Bowel Obstruction
- Trial name
- NCT01102283
- Testing
- Evolution(R) Colonic Stent
- Where
- 10 sites in Canada, Denmark and 5 more
- Volunteers
- 80 people
- Sponsor
- Cook Group Incorporated
Symptomatic Vascular Disease of the Iliac Arteries
FORMAT Clinical Study
The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of the Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease of the iliac arteries.
- Trial name
- NCT01804088
- Testing
- Formula™ 535 Iliac Balloon-Expandable Stent
- Where
- 12 sites in United States
- Volunteers
- 80 people
- Sponsor
- Cook Group Incorporated
Cardiac Electrophysiology
Transvenous Lead Removal Post-Market Clinical Study
This prospective, multicenter, post-market clinical study was designed to evaluate the outcomes of lead extraction of cardiovascular implantable electronic devices (CIED) using Cook catheter and lead extraction devices for any…
- Trial name
- NCT03688412
- Testing
- Cook lead extraction devices
- Where
- 9 sites in United States, Germany and 2 more
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Cook Research Incorporated
Breast Cancer, Breast Reconstruction
Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK Biodesign® Nipple Reconstruction Cylinder.
- Conditions
- Breast Cancer, Breast Reconstruction, Nipple Reconstruction
- Trial name
- NRC (NCT01216319)
- Testing
- Nipple reconstruction
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cook Group Incorporated
End-Stage Renal Disease
Cook Enforcer Post-Market Study
The purpose of this study is to evaluate the performance of the Cook Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter (or Enforcer balloon) in treating narrowed blood vessels compared to treatment with a conventional…
- Trial name
- NCT03552289
- Testing
- Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, Conventional angioplasty balloon catheters
- Where
- 5 sites in United States
- Volunteers
- 211 people
- Sponsor
- Cook Research Incorporated
Thoracic Aortic Aneurysm, Penetrating Aortic Ulcer
Zenith Thoracic Alpha (ZTA) Post-Market Data Collection
This study aims to gather real-world clinical data demonstrating the continued safety and performance of the a marketed stent graft (Zenith® Alpha Thoracic Endovascular Graft [ZTA]) and collect longer term follow-up to better…
- Trial name
- NCT06094127
- Testing
- Endovascular aortic treatment
- Where
- 10 sites in France, Germany and 2 more
- Volunteers
- 300 people
- Sponsor
- Cook Research Incorporated
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
Biliary Tract Neoplasms, Neoplasms
Evolution® Biliary Stent System Clinical Study
The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary…
- Conditions
- Biliary Tract Neoplasms, Neoplasms, Gastrointestinal Diseases, Digestive System Diseases
- Trial name
- NCT01962168
- Testing
- Evolution® Biliary Stent - Uncovered
- Where
- 9 sites in United States, Canada
- Volunteers
- 113 people
- Sponsor
- Cook Group Incorporated
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
Ischemia, Peripheral Arterial Disease
Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)
- Conditions
- Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases
- Trial name
- NCT02044666
- Testing
- Micronized Small Intestinal Submucosa (SIS)
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Cook Group Incorporated
Pulmonary Embolism
Cook IVC Filter Study
This prospective, multicenter, double-arm clinical study further evaluated the safety and effectiveness of Cook's commercially available inferior vena cava (IVC) filters (specifically, the Günther Tulip® Vena Cava Filter and Cook…
- Trial name
- CIVC (NCT02046096)
- Testing
- Günther Tulip® Vena Cava Filter, Cook Celect® Vena Cava Filters
- Where
- 28 sites in United States, Australia and 1 more
- Volunteers
- 473 people
- Sponsor
- Cook Research Incorporated
Venous Insufficiency of Leg
Cook Venous Valve System for Treatment of Chronic Venous Insufficiency
The purpose of this study is to learn about the safety, efficacy and utility of a medical device called the Cook® Venous Valve System.
- Trial name
- NCT05883943
- Testing
- Cook® Venous Valve System
- Where
- 3 sites in Colombia
- Volunteers
- 4 people
- Sponsor
- MED Institute Inc.
Premature Rupture of Fetal Membranes
Evaluation of CRB in PROM Patients
The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).
- Trial name
- NCT01736852
- Testing
- CRB, Pitocin
- Where
- 4 sites in United States
- Volunteers
- 129 people
- Sponsor
- Cook Group Incorporated
Urinary Incontinence, Stress
Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study
This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress urinary incontinence (SUI).
- Trial name
- NCT01382602
- Testing
- AMDC-USR
- Where
- 10 sites in Canada, Germany and 1 more
- Volunteers
- 150 people
- Sponsor
- Cook MyoSite
Pulmonary Embolism, Venous Thromboembolism
Celect Vena Cava Filter Clinical Trial
The clinical study will collect data to verify the safety and performance of the Cook Celect Filter in the prevention of pulmonary embolism (PE) in patients with a temporary or permanent high risk of thromboembolism.
- Trial name
- NCT00470626
- Testing
- Celect Vena Cava Filter
- Where
- 8 sites in Australia, Germany and 3 more
- Volunteers
- 129 people
- Sponsor
- Cook Group Incorporated
Urolithiasis
Ureteral Stent Study
The purpose of this study is to evaluate the feasibility of the Cook Ureteral Stent to reduce post-stent placement pain and urinary symptoms in patients following ureteroscopy for urolithiasis.
- Trial name
- NCT03043612
- Testing
- Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin, Cook Sof-Flex® Double Pigtail Ureteral Stent
- Where
- Hong Kong
- Volunteers
- 56 people
- Sponsor
- Cook Group Incorporated
Tumors (Others), Viscera
Cook iMRI Needles NSR Clinical Study
The purpose of this study is to evaluate the safety and performance of the Cook® iMRI Needle. This is an investigational needle that physicians can use to gain access to a particular part of the body, take a small sample of…
- Conditions
- Tumors (Others), Viscera, Masses
- Trial name
- NCT07783698
- Testing
- Percutaneous non-vascular access to anatomic structures
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cook Research Incorporated
Iliac Aneurysm, Aortic Aneurysm
Cook Iliac Branch Graft Post-market Registry
The Cook Iliac Branch Graft Post-market Registry will obtain case reports of physician experience with a CE-marked Cook Iliac Branch Graft to further confirm device safety and performance.
- Trial name
- NCT01055275
- Testing
- Implantation with a Cook Iliac Branch Graft
- Where
- Spain
- Volunteers
- 2 people
- Sponsor
- Cook Group Incorporated