Status:
COMPLETED
Ablation of Intestinal Metaplasia Containing Dysplasia
Lead Sponsor:
Medtronic - MITG
Collaborating Sponsors:
AstraZeneca
Conditions:
Barrett Esophagus
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if the intervention of a 510(k)-cleared endoscopically-guided (Halo Ablation systems), ablation system plus anti-secretory therapy is better than anti-secreto...
Detailed Description
Barrett's esophagus or intestinal metaplasia (IM) is a change in the epithelial lining of the esophagus. Barrett's esophagus develops as a result of chronic exposure of the esophagus to refluxed stoma...
Eligibility Criteria
Inclusion
- Subject is 18-80 years of age, inclusive. 2.Subject has documented diagnosis of IM, maximum endoscopic length of 8 cm (as measured endoscopically from the TGF to the most proximal extent of the IM; i.e. TGF-TIM containing dysplasia as follows:
- For LGD:i.LGD documented on biopsy within previous 12 months from enrollment while subject on PPI therapy.
- ii.Histology slides reviewed at central pathology service for trial confirm LGD on first confirmatory central pathology review or, if necessary, confirm LGD on a tie-breaker review by a second pathologist.
- For HGD:i.Regular, non-nodular, non-ulcerated mucosa. ii.HGD documented on biopsy within previous 6 months from enrollment. iii.Histology slides reviewed at central pathology service for Trial confirm HGD on first confirmatory review or, if necessary, confirm HGD on a tie-breaker review by a second pathologist.
- iv.Baseline EUS within previous 12 months; 1.Catheter-based EUS excludes suspicious thickened Barrett's areas or, if suspicious areas found, prompts stacked biopsies of thickened area, the results of which do not render subject ineligible for enrollment.
- For subjects with EMR history,the documented diagnosis of IM with dysplasia meets criterion #2 from biopsies collected either after the EMR procedure or during the EMR procedure but not from the EMR site.
- Subject able to take oral proton pump inhibitor medication. 5.Subject able to discontinue aspirin and/or non-steroidal anti-inflammatory medications 7 days before and after all ablation procedures.
- For female subjects of childbearing potential, a negative pregnancy test within 2 weeks of randomization.
- Subject eligible for treatment and follow-up endoscopy and biopsy as required by the Protocol.
- Subject willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation.
Exclusion
- The subject is pregnant or planning a pregnancy during the study period.
- Esophageal stricture preventing passage of endoscope or catheter. 3.Active esophagitis described as erosions or ulcerations encompassing more than 10% of distal esophagus.
- Any history of malignancy of the esophagus. 5.Prior radiation therapy to the esophagus,except head and neck region radiation therapy.
- Any previous ablative therapy within the esophagus (PDT, MPEC, APC, laser treatment, other).
- History of EMR that meets any of the following criteria:a.EMR performed less than 8 weeks prior to the randomization endoscopy encounter
- b.EMR performed in a wide field manner (encompassing more than 90 degrees of any area of the esophagus.
- Any previous esophageal surgery, including except fundoplication without complications (i.e. no slippage, dysphagia, etc).
- Evidence of esophageal varices during treatment endoscopy. 10.Report of uncontrolled coagulopathy with international normalized ratio (INR) \> 1.3 or platelet count \<75,000 platelets per µL 11.Subject has a life-expectancy of less than two years due to an underlying medical condition.
- Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
- 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.
- The subject is currently enrolled in an investigational drug or device trial that clinically interferes with the AIM Dysplasia Trial endpoints.
- Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol.
- For the 5 year extension, patient must have:1. Enrolled in the B-204 protocol. 2. Completed 1 year follow-up. 3. Completed 2 year follow-up.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00282672
Start Date
February 1 2006
End Date
August 1 2014
Last Update
November 6 2017
Active Locations (19)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
2
University of Arizona, VAMC
Tucson, Arizona, United States, 85723
3
UC Irvine Medical Center
Orange, California, United States, 92868
4
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224