Clinical trials: CryoAblation
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.
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.
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
Breast Cancer
Cryoablation of Small Breast Tumors in Early Stage Breast Cancer
This study examines the use of cryoablation as an alternative to surgery in the treatment of early stage invasive breast cancer.
- Trial name
- FROST (NCT01992250)
- Testing
- Visica 2 Treatment System
- Where
- 12 sites in United States
- Volunteers
- 200 people
- Sponsor
- Sanarus Technologies, Inc.
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
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
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 Flutter
Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial Flutter
The purpose of this study is to evaluate the safety and efficacy of right atrial intra-cardiac lesions created by transvenous catheter cryoablation in patients with atrial flutter.
- Trial name
- NCT00113178
- Testing
- Catheter-based cardiac cryoablation
- Volunteers
- 160 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
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
Esophageal Squamous Cell Dysplasia
Coldplay Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia
To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of esophageal squamous cell dysplasia.
- Trial name
- NCT02605759
- Testing
- CryoBalloon Focal Ablation System
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Pentax Medical
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
Atrial Fibrillation
Safety and Efficacy of CryoCor™ Cryoablation for PAF
A multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of PAF
- Trial name
- NCT00231296
- Testing
- Cardiac CryoCor Cryoablation System, Medical management
- Where
- 24 sites in United States
- Volunteers
- 174 people
- Sponsor
- Boston Scientific Corporation
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
Metastatic Cancer
In-Situ Therapeutic Cancer Vaccine for Metastatic Cancer Combining AlloStim With Tumor Cryoablation
This is a Phase I/II study to investigate the feasibility of creating a personalized therapeutic cancer vaccine within the body. A vaccine contains a source of tumor antigen and an adjuvant.
- Trial name
- NCT00861107
- Testing
- AlloStim-7, percutaneous tumor cryoablation, AlloStim8 or AlloStim-9
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mirror Biologics, Inc.
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.
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