Clinical trials: Cryoablation
Rhinitis
ClariFix Cryoablation Clinical Study
This is a single-arm pilot study designed to evaluate the feasibility of cryoablation in the nasal passageway, using the ClariFix device, to reduce the symptoms of chronic rhinitis.
- Trial name
- NCT02820597
- Testing
- ClariFix device
- Volunteers
- 27 people
- Sponsor
- Arrinex, Inc.
Tachycardia, Atrioventricular Nodal Reentry
CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
The purpose of this post approval study of heart block is to gather additional information regarding how often patients develop heart block (atrioventricular block) after having standard ablation procedure using cryotherapy with…
- Trial name
- PS-010 (NCT00621621)
- Testing
- Freezor® Cardiac Cryoablation Catheter CryoConsole System
- Where
- 4 sites in United States
- Volunteers
- 105 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Paroxysmal Atrial Fibrillation
A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada.
- Trial name
- Stop-AF (NCT00523978)
- Testing
- Arctic Front® Cryoablation Catheter, Flecainide or Sotalol or Propafenone
- Where
- 26 sites in United States, Canada
- Volunteers
- 245 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
POLARx Cardiac Cryoablation System Study
This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.
- Trial name
- POLAR ICE (NCT04250714)
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 19 sites in Belgium, Croatia and 5 more
- Volunteers
- 400 people
- Sponsor
- Boston Scientific Corporation
Warts, Warts Hand
CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts
This prospective, multicenter, single-blinded, randomized comparison study is designed to compare the safety and effectiveness of the CellFX System to Cryosurgery for the clearance of cutaneous non-genital common warts on all…
- Conditions
- Warts, Warts Hand, Verruca
- Trial name
- NCT04738734
- Testing
- CellFX System Device, Cryosurgery Liquid Nitrogen Sprayer
- Where
- 10 sites in United States
- Volunteers
- 150 people
- Sponsor
- Pulse Biosciences, Inc.
Chronic Rhinitis
ClariFix Rhinitis RCT
A randomized, sham-controlled, single-blind study of cryotherapy as a treatment for chronic rhinitis.
- Trial name
- CR RCT (NCT04154605)
- Testing
- ClariFix cryotherapy
- Where
- United States
- Volunteers
- 133 people
- Sponsor
- Stryker Instruments
Monomorphic Ventricular Tachycardia
Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT)
A prospective, single-arm, multi-center, pre-market, clinical study designed to provide safety and performance data regarding the use of the Adagio Medical VT Cryoablation System in the treatment of ventricular tachycardia.
- Trial name
- CryoCure-VT (NCT04893317)
- Testing
- Ablation in the ventricles with the Adagio Medical VT Cryoablation System
- Where
- 7 sites in Belgium, Canada and 4 more
- Volunteers
- 64 people
- Sponsor
- Adagio Medical
Actinic Keratosis
Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery
The objective of this study is to evaluate the efficacy and safety of imiquimod cream versus placebo cream when used after cryosurgery in the treatment of actinic keratoses (AKs).
- Trial name
- NCT00894647
- Testing
- imiquimod cream
- Where
- 18 sites in United States, Canada
- Volunteers
- 247 people
- Sponsor
- Graceway Pharmaceuticals, LLC
Atrial Fibrillation
Continued Access Protocol
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review.
- Trial name
- CAP-AF (NCT00889681)
- Testing
- Arctic Front Cardiac Cryoablation System
- Where
- 10 sites in United States
- Volunteers
- 81 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
Left atrial catheter ablation including pulmonary vein isolation is a standard therapy in the management of symptomatic atrial fibrillation; however thermal esophageal injury is a known potential consequence of this procedure.
- Trial name
- NCT04087122
- Testing
- Esophageal warming device (Attune Medical, Chicago, IL
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Atrial Fibrillation
Spanish Registry of Cryoballoon Ablation
The purpose of this registry is to reflect on standard clinical practice in pulmonary vein cryoablation in Spanish hospitals, the different procedure protocols, details of intervention, complications, long-term follow-up strategy…
- Trial name
- RECABA (NCT02785991)
- Testing
- Balloon cryoablation
- Where
- 28 sites in Spain
- Volunteers
- 1,742 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation, Atrial Flutter
FREEZE-AFIB Post-Market Study
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.
- Trial name
- NCT05089877
- Testing
- Surgical Ablation
- Where
- 6 sites in United States
- Volunteers
- 39 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
Cryoablation System FIM/CE Mark Study
Multi-center, open label, prospective clinical study to establish the acute safety and performance of the Cryterion Cardiac Cryoablation System
- Trial name
- NCT03723070
- Testing
- The Cryterion Cardiac Cryoablation System
- Where
- 4 sites in Croatia, Netherlands and 1 more
- Volunteers
- 88 people
- Sponsor
- Boston Scientific Corporation
Kidney Neoplasms
Tracking Renal Tumors After Cryoablation Evaluation
TRACE is an observational, open-label, single-arm, multi-center registry of subjects who have undergone renal lesion cryoablation per their physician's standard of care.
- Trial name
- TRACE (NCT01117779)
- Testing
- Cryoablation
- Where
- 7 sites in United States
- Volunteers
- 246 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).
- Trial name
- FROZEN-AF (NCT04133168)
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 44 sites in United States, Belgium and 7 more
- Volunteers
- 458 people
- Sponsor
- Boston Scientific Corporation
Breast Cancer
Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial
To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .
- Trial name
- NCT02200705
- Testing
- Ice-Sense3TM/ ProSenseTM
- Where
- 19 sites in United States
- Volunteers
- 206 people
- Sponsor
- IceCure Medical Ltd.
Neoplasm Metastasis
Study of Cryoablation for Metastatic Lung Tumors
The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in participants with pulmonary metastatic disease.
- Trial name
- SOLSTICE (NCT01957787)
- Testing
- Cryoablation
- Where
- 10 sites in United States, France
- Volunteers
- 131 people
- Sponsor
- Boston Scientific Corporation
Chronic Rhinitis
Evaluation of the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis
A multi-center, prospective, non-randomized, interventional clinical trial to assess the safety and effectiveness of the ClariFix™ device when used to ablate unwanted tissue in the nose of subjects with chronic rhinitis.
- Trial name
- FROST (NCT03181594)
- Testing
- ClariFix Device
- Where
- 6 sites in United States
- Volunteers
- 100 people
- Sponsor
- Arrinex, Inc.
Paroxysmal Atrial Fibrillation (PAF)
Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.
- Trial name
- STOP AF PAS (NCT01456949)
- Testing
- Medtronic Arctic Front® Cardiac CryoAblation System
- Where
- 39 sites in United States, Canada
- Volunteers
- 402 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Metastatic Lung Cancer
Safety and Efficacy of Cryoablation for Metastatic Lung Tumors
ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors less than or equal to 3.5 centimeters (cm) in participants with pulmonary metastatic disease.
- Trial name
- ECLIPSE (NCT01307501)
- Testing
- Cryoablation
- Where
- 4 sites in United States, France
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation