Clinical trials: Cryoablation
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 Colorectal Cancer
AlloStim® In-Situ Vaccine in Pre-Treated Metastatic Colorectal Cancer
This is a personalized anti-cancer vaccine protocol which includes an in-situ (in the body) cancer vaccine step which combines killing a single metastatic tumor lesion by use of cryoablation in order to cause the release of…
- Trial name
- NCT01741038
- Testing
- AlloStim®, cryoablation, Physician's Choice (PC)
- Where
- Thailand
- Sponsor
- Mirror Biologics, Inc.
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
Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation
A prospective, two-arm, multi-center, randomized, open-label, pre-market, First-in-Human clinical study designed to provide safety and performance data regarding the use of the Adagio PFA and PFCA Systems in the treatment of PsAF.
- Trial name
- PARALELL (NCT05408754)
- Testing
- Atrial ablation for subject scheduled for a de novo endocardial ablation of symptomatic, drug-refractory PsAF.
- Where
- 6 sites in Belgium, Canada and 4 more
- Volunteers
- 89 people
- Sponsor
- Adagio Medical
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.
Atrial Fibrillation
Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)
The purpose of this clinical study is to assess the single procedure outcomes of using cryoballoon ablation without additional empirical lesions and/or complex fractionated electrogram (CFE) ablations for patients with early…
- Trial name
- NCT02213731
- Testing
- Holter monitoring
- Where
- 14 sites in France, Germany and 1 more
- Volunteers
- 130 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
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
Heavy Menstrual Bleeding, Abnormal Uterine Bleeding
A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device
Channel Medsystems, Inc., the manufacturer of the Cerene® Cryotherapy Device (Cerene), is initiating a prospective, observational registry, the Progress registry, to gather data during real world utilization of the Cerene®…
- Conditions
- Heavy Menstrual Bleeding, Abnormal Uterine Bleeding, Menorrhagia
- Trial name
- Progress (NCT05922657)
- Testing
- Cerene
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Channel Medsystems
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
Paroxysmal Atrial Fibrillation (PAF)
A Clinical Study on the Use of a Domestically Produced Cryoablation System Combined With Balloon Cryoablation Technology for the Treatment of Paroxysmal Atrial Fibrillation
To validate the safety and efficacy of balloon cryoablation technology and the accompanying disposable intracardiac mapping electrode catheter and adjustable guide sheath for the treatment of paroxysmal atrial fibrillation.
- Trial name
- Balloon cryoab (NCT07036068)
- Testing
- IceMagic™ CryoAblation Catheter
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
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.
Ventricular Tachycardia, Sustained, Ventricular Tachycardia, Monomorphic
Cryoablation for Monomorphic Ventricular Tachycardia (VTS)
The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio Medical vCLAS Ventricular Ablation System (including VTS Catheter and Console) in the ablation treatment of Sustained Monomorphic…
- Trial name
- FULCRUM-VT (NCT07650032)
- Testing
- Ultra Low Temperature Ablation (ULTA)
- Where
- 10 sites in United States, Canada
- Volunteers
- 100 people
- Sponsor
- Adagio Medical
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
Atrial Fibrillation, Atrial Flutter
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
A prospective, single-arm, multi-center study designed to collect real world safety and performance data of the Adagio Medical iCLAS Cryoablation System in the treatment of drug refractory, recurrent, symptomatic, Paroxysmal…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- NCT05416086
- Testing
- cryoablation procedure using the iCLAS Cryoablation System
- Where
- 4 sites in Belgium, Germany and 1 more
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Adagio Medical
Pain, Neoplasm Metastasis
Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases
This study will evaluate the efficacy of cryoablation for palliation of painful metastases in participants with metastatic lesions involving bone who have failed, are not candidates for, or are not experiencing adequate pain…
- Conditions
- Pain, Neoplasm Metastasis, Bone Metastasis of Diverse Origins
- Trial name
- MOTION (NCT02511678)
- Testing
- Cryoablation
- Where
- 11 sites in United States, France
- Volunteers
- 73 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.
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
Paroxysmal Atrial Fibrillation
POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART)
This is a post-market study collecting real-world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System (POLARx™ System)
- Trial name
- POLAR SMART (NCT05282823)
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 19 sites in Japan, South Korea
- Volunteers
- 295 people
- Sponsor
- Boston Scientific Corporation
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.