Clinical trials: Cryoablation
Ventricular Tachycardia
VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
The PMCF is a prospective, single-arm, multi-center, controlled study of up to 130 patients designed to collect safety and performance data regarding the use of the Adagio VT Cryoablation System in the treatment of recurrent…
- Trial name
- NCT06384599
- Testing
- VT Cryoablation System
- Where
- United Kingdom
- Volunteers
- 130 people
- Sponsor
- Adagio Medical
Barrett's Esophagus, Esophageal Cancer
Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium
The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.
- Trial name
- NCT01293448
- Testing
- Cryoballoon Ablation
- Where
- 4 sites in United States, Netherlands
- Volunteers
- 21 people
- Sponsor
- Pentax Medical
Low-Risk, Early Stage Breast Cancer
Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)
The FDA has granted marketing authorization for the ProSense® Cryoablation System for the local treatment of patients aged 70 years or older with low-risk early-stage breast cancer who are also receiving adjuvant hormone therapy.
- Trial name
- NCT07629206
- Testing
- Cryoablation
- Where
- 3 sites in United States
- Volunteers
- 400 people
- Sponsor
- IceCure Medical Ltd.
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
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
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
Prostate Cancer
Phase I Clinical Trial of Cryoimmunotherapy Against Prostate Cancer
20 patients with invasive castration resistant prostate cancer and radiologically verified metastases will be enrolled into the Phase I Clinical Trial. The trial is a dendritic cell based immunotherapy.
- Trial name
- CryoIT (NCT02423928)
- Testing
- Dendritic cell based cryoimmunotherapy, Cyclophosphamide, ipilimumab
- Where
- Norway
- Volunteers
- 18 people
- Sponsor
- Alden Cancer Therapy II
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
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
Pain, Neoplasm Metastasis
Safety and Efficacy of Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases
This study will evaluate the safety and efficacy of cryoablation therapy combined with radiation therapy for the relief of pain associated with metastatic bone tumors.
- Trial name
- NCT01461252
- Testing
- Cryoablation, Radiation
- Sponsor
- Boston Scientific Corporation
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
Symptomatic Paroxysmal Atrial Fibrillation Without Clinically Significant Heart Diseases
Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation
The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI) performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line therapy in comparison with antiarrhythmic…
- Trial name
- NCT01803438
- Testing
- cryoballoon ablation system, Antiarrhythmic Drugs
- Where
- 19 sites in Argentina, Australia and 7 more
- Volunteers
- 220 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
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.
Symptomatic Uterine Fibroids
Laparoscopic Cryoablation of Uterine Fibroids
The goal of this study is to evaluate the safety \& efficacy of cryoablation using IceCure medical's IceSense3™ device for the treatment of symptomatic uterine fibroids in a percutaneous lap-assisted approach.
- Trial name
- UFREEZE-01 (NCT01735812)
- Testing
- IceSense3 system
- Where
- Israel
- Sponsor
- IceCure Medical Ltd.
Metastatic Breast Cancer
Increased Frequency of AlloStim(TM) Dosing in Combination With Cryoablation in Metastatic Breast Cancer Patients
This phase I/II study is designed to compare different treatment schedules of a personalized anti-cancer vaccine protocol which combines the cryoablation of a selected metastatic lesion with intra-tumor immunotherapy.
- Trial name
- MBC (NCT02018419)
- Testing
- AlloStim, Cryoablation
- Where
- United States
- Sponsor
- Mirror Biologics, Inc.
Kidney Tumors
Electromagnetic Tracking of Devices During Interventional Procedures - A Cryoablation Study
The objective of this study is to assess and quantify any differences between assisted (using real-time visualization of tracked cryo-probes) and unassisted cryoablation procedures using pre-procedure CT scans or CT fluoroscopy…
- Trial name
- NCT01401777
- Where
- United States
- Sponsor
- Philips Healthcare
Paroxysmal Atrial Fibrillation
Treatment of PAF With the Synaptic System
Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI.
- Trial name
- Sensation (NCT05905835)
- Testing
- Synaptic Cryoablation System
- Where
- 10 sites in United States
- Volunteers
- 128 people
- Sponsor
- Synaptic Medical Corporation
Atrial Flutter
Prospective, Multicenter, Investigation of the Adagio Cryoablation System in Subjects With Atrial Flutter
The objective of the study is to demonstrate the safety and feasibility of the Adagio System in subjects with Atrial Flutter.
- Trial name
- NCT02355106
- Testing
- PolarStart System
- Where
- 2 sites in Belgium, Netherlands
- Volunteers
- 17 people
- Sponsor
- Adagio Medical