Micro-Layer Ablation of Barrett's Metaplasia- A Two-Phase, Multi-Center Trial - Extension of Follow-up to 5 Years
Condition: Barrett Esophagus
MeSH terms: Barrett Esophagus; Metaplasia
Study type: Interventional

Summary: 
      This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to
      evaluate a balloon-based ablation device (HALO360) that delivers a pre-set amount of energy
      density (J/cm2) to barrett's tissue. The dosimetry phase evaluated the dose-response and the
      safety of delivering 6 to 12 J/cm2. The effectiveness phase used 10 J/cm2 delivered twice for
      all patients, followed by Esophagogastroduodenoscopy (EGD) with biopsies at 1, 3, 6, and 12
      months. A second ablation procedure was performed if Barretts esophagus (BE) was present at 1
      or 3 months. A complete response (CR) was defined as all biopsy specimens negative for
      Barrett's Esophagus at 12 months. The effectiveness phase of the present study was extended
      to a 2.5-year follow-up. This trial incorporated an opportunity for persistent BE to be
      treated with a focal ablation device (HALO90), achieving a CR in 98.4% of patients by the
      2.5-year follow-up,the results of which were published . There is ample evidence that
      RadioFrequency Ablation (RFA) for Barrett's esophagus is effective and safe. Having
      additional follow-up (5 years) would add valuable information to the literature, thus aiding
      the physician in making patient management decisions about the appropriate follow-up interval
      after RFA.
    

Detailed description: 
      This study is intended to gather additional information regarding the performance of a
      bipolar balloon electrode device (HALO360) utilizing radiofrequency (RF) energy in the
      micro-layer ablation of Barrett's esophagus, a precancerous, metaplastic change in the
      esophageal lining. The device has received 510(k) clearance for specific indications,
      including the treatment of Barrett's esophagus.

      This study is conducted in two phases and is intended to further evaluate the effect of
      micro-layer ablation of Barrett's metaplasia using a 510(k) cleared, bipolar, balloon
      electrode device. Phase I (n=30) is intended to provide additional information regarding the
      effects of three randomized treatment parameters (energy settings, Joules/cm2). Phase II
      (n=70) is intended to provide additional information regarding the effects of the optimal
      technique and energy density settings (Joules/cm2) determined from the 1-month endoscopy
      results of Phase I. Phase 2 primary endpoint was histological clearance of Barrett's (%
      patients). This trial incorporated an opportunity for persistent BE to be treated with a
      focal ablation device (HALO90), at the 2.5-year follow-up, achieving a CR in 98.4% of
      patients. Having additional follow-up (5 years) would add valuable information to the
      literature, thus aiding the physician in making patient management decisions about the
      appropriate follow-up interval after RFA. This study will allow collection of 5-year
      follow-up biopsies and, thereafter, offer RFA for any subject with persistent Barrett's.

      Upon approval of the present amendment to the protocol (B-200-5 year extension) and the
      informed consent form (ICF) at each study site, subjects who participated in B-200-2.5 year
      extension and had a biopsy at 2.5 years after initial enrollment will be offered
      participation in this extension.
    

Intervention name(s): HALO Ablation System
Intervention type(s): Device
Intervention description(s): Phase I: 1-2 ablation visits; Phase II 1 to 12 months: 1-2 ablation visits; Phase II 12 to 30 months: 1-3 ablation visits Phase II 55-60 months: 0-1 ablation visit
******Phase I was a dosimetry study and Phase II used the preferred dose. The same intervention was used for each dose.
Other intervention name(s): HALO360; HALO90
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Barrett's Esophagus; Intestinal Metaplasia; Radiofrequency Ablation