Clinical trials: Cryoablation
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
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
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
Colorectal Cancer Metastatic
AlloStim® Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer
This is a single center, open label dose frequency escalation study of CryoVax®. personalized anti-tumor vaccine protocol combining the cryoablation of a selected metastatic lesion with intra-lesional immunotherapy with…
- Trial name
- NCT02380443
- Testing
- AlloStim, Cryoablation
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Mirror Biologics, Inc.
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
Prostate Cancer
Safety Study of Autologous Dendritic Cells Injected Into the Prostate After Cryoablation for Advanced Prostate Cancer
The purpose of this study is to determine if the intra-tumoral injection of a subject's own dendritic cells after cryotherapy of the prostate is a safe and effective treatment for advanced prostate cancer.
- Trial name
- CRITICAL (NCT00753220)
- Testing
- VDC2008, Cyclophosphamide
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Bostwick Laboratories
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
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.
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
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
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
AtrioVentricular Nodal Reentrant Tachycardia, Supraventricular Tachycardia
Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia) is a prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational clinical study.
- Conditions
- AtrioVentricular Nodal Reentrant Tachycardia, Supraventricular Tachycardia, Heart Disease
- Trial name
- NCT01426425
- Testing
- Freezor Xtra Cryoablation Catheter
- Where
- 34 sites in United States, Canada
- Volunteers
- 572 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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.
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
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
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
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
Menorrhagia
Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System
The Her Option® Cryoablation Therapy System is a closed-loop cryosurgical device that is used to ablate the endometrial lining in pre-menopausal women with menorrhagia (excessive menstrual bleeding) due to benign causes.
- Trial name
- NCT00094536
- Testing
- Extended treatment regimen using Her Option Cryotherapy
- Where
- 7 sites in United States
- Volunteers
- 82 people
- Sponsor
- CooperSurgical Inc.
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
Uterine Fibroids, Leiomyoma
Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata
The purpose of the current study is to evaluate the technical success, safety and procedure feasibility of hysteroscopic cryoablation treatment of symptomatic uterine fibroids in women who do not desire further pregnancies using…
- Conditions
- Uterine Fibroids, Leiomyoma, Menorrhagia
- Trial name
- NCT00731341
- Testing
- Cryoablation for the treatment of uterine fibroids
- Where
- Netherlands
- Volunteers
- 3 people
- Sponsor
- Boston Scientific Corporation