N/A
N=102
Micro-Layer Ablation of Barrett's Metaplasia- A Two-Phase, Multi-Center Trial - Extension of Follow-up to 5 Years
Barrett Esophagus
Bottom Line
View on ClinicalTrials.gov: NCT00489268 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Percentage of Participants With Histological Clearance of Barrett's Metaplasia — 100; 20; 78; 82 Percent of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HALO Ablation System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Covidien, GI Solutions
- Primary completion
- Feb 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Histological Clearance of Barrett's Metaplasia |
100; 20; 78; 82; 92 | — |
| SECONDARY Progression of Histological Grade |
0; 0; 0; 0; 0 | — |
| SECONDARY Adverse Events |
0; 0; 7; 0; 28 | — |
| SECONDARY Percentage of Participants With Sub-squamous Intestinal Metaplasia |
0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- Barrett metaplasia endoscopic length:
Phase I : 2-3 cm Barrett's length (inclusive) Phase II: 2-6 cm Barrett's length (inclusive)
- Age 18-75 years inclusive
- Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form
- 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
- Subjects is pregnant or planning a pregnancy
- Esophageal stricture preventing passage of endoscope or catheter
- Active esophagitis (Hetzel-Dent Grade III or IV) described as erosions or ulcerations encompassing more than 10% of distal esophagus
- Barrett's metaplasia with dysplasia (any previous biopsy)
- History or current diagnosis of malignancy of the esophagus
- Prior radiation therapy to the esophagus, except head and neck region radiation therapy
- Any previous ablative therapy within the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment, or other)
- Any previous endoscopic mucosal resection within the esophagus
- Any previous esophageal surgery, except fundoplication
- Esophageal varices
- 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
- Participation in another clinical study in past 60 days
- Subject suffers from unstable psychiatric disorder(s)
Data sourced from ClinicalTrials.gov (NCT00489268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.