Healthcare Professionals
Clinical Evidence Supports RFA Therapy
Through rigorous clinical trials, the HALO ablation system has demonstrated exceptional safety and efficacy. The following chart details the current trial and publication status of studies evaluating HALO.
Clinical Safety
The HALO Ablation Systems have demonstrated significant safety. From April 2005 through June 2011, more than 85,000 procedures have been performed.
- The cumulative stricture rate is (n=145) 0.17%
- The perforation rate (n=11) is 0.01%
- The cumulative reportable event rate per procedure is 0.22%
There have been no deaths attributable to HALO RFA therapy.30
NOTE: For a full listing of contraindications, warnings and precautions, please refer to the Instructions For Use (IFU) for all HALO Ablation System products.
Clinical Trial Publications Summary
There is a growing body of evidence and experience for intervention with HALO technology in treating patients with BE, GAVE and RP. CLICK HERE to see a selected summary of published trials, reviews, and abstracts.
Clinical Data Summary
Barrx Medical, Inc. will continue to invest in clinical trials and partner with the medical community to provide studies on our HALO technology. The above clinical data and ongoing trials illustrate our investment and dedication to sound science and proof that our technology works. CLICK HERE to see a summary of some of the data collected from over 50 peer reviewed publications.
U.S. Barrett’s RFA Registry
The U.S. Barrett’s RFA Registry is a prospective, web-based, multicenter registry. It enables participating physicians to track outcomes for all patients with Barrett’s esophagus (with or without dysplasia) who undergo RFA treatment.
Registry participants are expert physicians from university-based and community-based practices, all of whom have a common interest in the diagnosis and treatment of Barrett’s esophagus. All participating centers follow a standardized IRB approved study protocol.
The U.S. Barrett’s RFA Registry is the largest prospective trial in Barrett’s endotherapy ever conducted. The registry was initiated in 2007. To date, there are over 5,000 patients enrolled at 163 centers. The study tracks:
- Histological clearance rate for IM (CR-IM)
- Histological clearance rate for dysplasia (CR-D)
- Endoscopic clearance rate for BE
- SSIM (at last versus any biopsy session)
- QOL (baseline versus 12 month)
- AE incidence
- CR by Kaplan Meier survival analysis
- Neoplastic progression
- Outcomes for progressors
Clinical Trial Investigators
View list of clinical investigators involved in one or more studies evaulating the HALO technology.
