Micro-Layer Ablation of Barrett's Metaplasia- A Two-Phase, Multi-Center Trial - Extension of Follow-up to 5 Years

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.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

1. Subject has documented histopathological diagnosis of Barrett's metaplasia (without dysplasia) as follows:

   * biopsies obtained less than 6 months prior to enrollment, and
   * biopsies obtained and reviewed at the investigator institution, and
   * biopsy protocol included at least 4 quadrant biopsies per 2 cm length of Barrett's metaplasia
2. Barrett metaplasia endoscopic length:

   Phase I : 2-3 cm Barrett's length (inclusive) Phase II: 2-6 cm Barrett's length (inclusive)
3. Age 18-75 years inclusive
4. Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form
5. Five year extension: All subjects who participated in B-200-2.5 year extension and had a biopsy at 2.5 years after initial enrollment (n=61) will be offered participation in this extension.

Exclusion Criteria:

1. Subjects is pregnant or planning a pregnancy
2. Esophageal stricture preventing passage of endoscope or catheter
3. Active esophagitis (Hetzel-Dent Grade III or IV) described as erosions or ulcerations encompassing more than 10% of distal esophagus
4. Barrett's metaplasia with dysplasia (any previous biopsy)
5. History or current diagnosis of malignancy of the esophagus
6. Prior radiation therapy to the esophagus, except head and neck region radiation therapy
7. Any previous ablative therapy within the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment, or other)
8. Any previous endoscopic mucosal resection within the esophagus
9. Any previous esophageal surgery, except fundoplication
10. Esophageal varices
11. Subject has an implantable pacing device (examples; AICD, neurostimulator, cardiac pacemaker) and has not received clearance for enrollment in this study by specialist responsible for the pacing device
12. Participation in another clinical study in past 60 days
13. Subject suffers from unstable psychiatric disorder(s)

• RESULTSharma VK, Wang KK, Overholt BF, Lightdale CJ, Fennerty MB, Dean PJ, Pleskow DK, Chuttani R, Reymunde A, Santiago N, Chang KJ, Kimmey MB, Fleischer DE. Balloon-based, circumferential, endoscopic radiofrequency ablation of Barrett's esophagus: 1-year follow-up of 100 patients. Gastrointest Endosc. 2007 Feb;65(2):185-95. doi: 10.1016/j.gie.2006.09.033. PMID 17258973
• RESULTFleischer DE, Overholt BF, Sharma VK, Reymunde A, Kimmey MB, Chuttani R, Chang KJ, Lightdale CJ, Santiago N, Pleskow DK, Dean PJ, Wang KK. Endoscopic ablation of Barrett's esophagus: a multicenter study with 2.5-year follow-up. Gastrointest Endosc. 2008 Nov;68(5):867-76. doi: 10.1016/j.gie.2008.03.008. Epub 2008 Jun 17. PMID 18561930
• RESULTFleischer DE, Overholt BF, Sharma VK, Reymunde A, Kimmey MB, Chuttani R, Chang KJ, Muthasamy R, Lightdale CJ, Santiago N, Pleskow DK, Dean PJ, Wang KK. Endoscopic radiofrequency ablation for Barrett's esophagus: 5-year outcomes from a prospective multicenter trial. Endoscopy. 2010 Oct;42(10):781-9. doi: 10.1055/s-0030-1255779. Epub 2010 Sep 20. PMID 20857372