Clinical trials: CryoAblation
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
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 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
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.
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.
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
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
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
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.
Atrial Fibrillation, Atrial Flutter
Investigation of the Adagio Cryoablation System in Patients With Atrial Fibrillation
The objective of the study is to demonstrate the safety and feasibility of the Adagio Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing Persistent Atrial Fibrillation.
- Trial name
- CryoCure2 (NCT02839304)
- Testing
- Cryoablation System
- Where
- 3 sites in Belgium, France and 1 more
- Volunteers
- 80 people
- Sponsor
- Adagio Medical
Sustained VT
Cryoablation for Monomorphic Ventricular Tachycardia
The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT)
- Trial name
- FULCRUM-VT (NCT05675865)
- Testing
- cryoablation procedure
- Where
- 15 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- Adagio Medical
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
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.
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
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
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
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
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.