Barrett Esophagus
Conditions
Keywords
Barrett's Esophagus, Dysplasia, Radiofrequency Ablation
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-secretory therapy alone in clearing Barrett's Esophagus.
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 stomach acid and enzymes, as well as bile, resulting in recurrent mucosal injury. Injury is accompanied by inflammation and, ultimately, a cellular change (metaplasia) to a specialized columnar epithelium (Spechler SJ. Barrett's Esophagus. N Engl J Med 2002;346(11):836-842.) Patients who have a diagnosis of Barrett's esophagus typically undergo surveillance endoscopy every 1-3 years with multiple biopsy specimens obtained to facilitate early detection of progression of IM to dysplasia (more severe precancerous changes) and adenocarcinoma. (Sampliner RE. Updated guidelines for the diagnosis, surveillance, and therapy of Barrett's esophagus. Am J Gastro 2002;97:1888-1895.) Progression of IM to low-grade dysplasia (LGD) indicates that cells exhibit more cancer-like architecture, thus warranting an accelerated surveillance endoscopy and biopsy program every 6 months rather than every 1-3 years as indicated for non-dysplastic IM. Progression to high-grade dysplasia (HGD) indicates that the cells are even more cancer-like, thus warranting an even higher frequency surveillance endoscopy and biopsy program (every 3 months). Many HGD patients may undergo photodynamic therapy (PDT) or surgical esophagectomy, rather than remain in a frequent surveillance program. This more aggressive therapy is warranted because of the high rate of progression of HGD to adenocarcinoma. Esophageal adenocarcinoma most commonly occurs after an insidious progression from IM to LGD to HGD. Therefore, surveillance is increased upon diagnosis of worsening grades of dysplasia. The incidence of esophageal adenocarcinoma is rapidly increasing as middle-aged and elderly demographic sub-groups expand (Peters JH, Hagen JA, DeMeester SR. Barrett's Esophagus. J Gastrointest Surg 2004;8(1):1-17.) In 2004, the American Cancer Society reported that there were 14,250 new cases of esophageal cancer, and 13,300 deaths attributable to esophageal cancer (www.cancer.org). The U.S. National Cancer Institute Surveillance, Epidemiology and End Results Program reported that the increasing incidence of esophageal adenocarcinoma was greater than for any other cancer in the United States (www.cancer.gov). Elimination of the diseased epithelium containing IM with dysplasia is an intuitively favorable step for patients with this diagnosis. In other disease states, such as colon polyps or premalignant skin lesions, removal of the premalignant tissue results in a reduction in the risk of ultimately developing cancer. This is a logical conclusion when considering the premalignant lesion of Barrett's esophagus (particularly Barrett's esophagus with dysplasia), as the tissue at risk can be completely removed by ablation. This premise has been tested in the Barrett's dysplasia population in photoablative trials using PDT for patients with HGD, where PDT imparted a 50% reduction in risk over controls for the development of adenocarcinoma (Overholt BF, Panjehpour M, Haydek JM. Photodynamic therapy for Barrett's esophagus: follow-up. Gastrointest Endosc 1999;49(1):1-7.) The AIM Dysplasia Trial primary endpoints are removal of all dysplasia and IM, rather than detection of a difference in progression to adenocarcinoma or higher grades of dysplasia.
Interventions
DEVICEAblation System plus anti-secretory medication
Treatment group subjects undergo up to 4 ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI).
DEVICESham procedure plus anti-secretory medication
The Sham Control group undergo an upper endoscopy procedure with sizing of the esophageal diameter (a component of the ablation procedure steps, deemed the sham procedure) plus standard anti-secretory drug therapy (Proton pump inhibitor, PPI)
Sponsors
AstraZeneca
Medtronic - MITG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1.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: 1. 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. 2. 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. 3.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. 4.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. 6.For female subjects of childbearing potential, a negative pregnancy test within 2 weeks of randomization. 7.Subject eligible for treatment and follow-up endoscopy and biopsy as required by the Protocol. 8.Subject willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation.
Exclusion criteria
1.The subject is pregnant or planning a pregnancy during the study period. 2.Esophageal stricture preventing passage of endoscope or catheter. 3.Active esophagitis described as erosions or ulcerations encompassing more than 10% of distal esophagus. 4.Any history of malignancy of the esophagus. 5.Prior radiation therapy to the esophagus,except head and neck region radiation therapy. 6.Any previous ablative therapy within the esophagus (PDT, MPEC, APC, laser treatment, other). 7.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. 8.Any previous esophageal surgery, including except fundoplication without complications (i.e. no slippage, dysphagia, etc). 9.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. 12.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. 13.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. 14.The subject is currently enrolled in an investigational drug or device trial that clinically interferes with the AIM Dysplasia Trial endpoints. 15.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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The % of Patients With Complete Eradication of Intestinal Metaplasia (IM) at 12 Month | 12 month | % of patients with complete eradication of IM out of the number of participants analyzed at 12 month was calculated. |
| The % of Patients With Complete Eradication of Dysplasia at 12 Month | 12 month | % of patients with complete eradication of Dysplasia out of the number of participants analyzed at 12 month was calculated. |
| The % of Patients With Complete Histological Clearance of Intestinal Metaplasia at 24 Months. | 24 Month | % of patients with complete eradication of IM out of the number of participants analyzed at 24 month was calculated. |
| 5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Years | 5 years | For patient who made it to the 5 year visit, % of patients demonstrating complete eradication of intestinal metaplasia (CE-IM) was calculated. |
| Durability of Eradication With no Additional Treatments | 5 year | — |
| 5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Years | 5 years | For patient who made it to the 5 year visit, % of patients demonstrating complete eradication of dysplasia was calculated and all were free of dysplasia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Incidence | 12 months for Treatment and Sham Comparison | Data reported in the adverse event section |
| For 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body Since Primary RFA (0-5 Years) | 5 years | — |
| 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body After 2 Years and Inclusive of the 5 Year Visit | 5 years | — |
| 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Year | 5 years | — |
| 5 Year Extension:Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Year | 5 years | — |
| The % of Patients With Complete Histological Clearance of IM at 12 Months, Comparing Treatment Versus Sham Control Groups Within a Specific Dysplasia Subgroup | 12 months | — |
| 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 3 Year | 3 years | — |
| 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 4 Year | 4 years | — |
| 5 Year Extension: Serious Adverse Event Incidence | 5 years | — |
| 5 Year Extension: All Cause Mortality of the Group From 2 to 5 Years. | 5 years | — |
| 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 4 Year | 4 years | — |
| Within the HGD Subgroup, the % of Patients With Complete Histological Clearance of HGD (CR-D) at 12 Months, Comparing Treatment Versus Sham Control Groups. | 12 Month | — |
| Histological Clearance of IM (% Biopsies) | 12 months | % of patients with histological clearance of IM out of the number of participants analyzed at 12 month was calculated. |
| Progression of Dysplasia (i.e., HGD to Adenocarcinoma, or LGD to HGD or Adenocarcinoma) | 5 year | — |
| Subject Discomfort : Chest Pain Score on Day 1 | Day 1 , if ablated | Chest pain score was measured on a visual analogue scale of 0 to 100, with higher scores indicating a greater severity of pain |
| Quality of Life Questionnaire (Baseline v. 12 and 24 Mos) | 0, 12, and 24 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LGD Sham Procedure First Then LGD Radiofrequency Ablation After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA. | 22 |
| LGD Radiofrequency Ablation | 42 |
| HGD Sham Procedure First Then LGD Radiofrequency Ablation After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA. | 21 |
| HGD Radiofrequency Ablation | 42 |
| Total | 127 |
Baseline characteristics
| Characteristic | LGD Sham Procedure First Then LGD Radiofrequency Ablation | LGD Radiofrequency Ablation | HGD Sham Procedure First Then LGD Radiofrequency Ablation | HGD Radiofrequency Ablation | Total |
|---|---|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 1.9 | 66.3 years STANDARD_DEVIATION 1.4 | 67.3 years STANDARD_DEVIATION 1.8 | 65.9 years STANDARD_DEVIATION 1.4 | 65.95 years STANDARD_DEVIATION 8.95 |
| Region of Enrollment United States | 22 participants | 42 participants | 21 participants | 42 participants | 127 participants |
| Sex: Female, Male Female | 3 Participants | 9 Participants | 0 Participants | 5 Participants | 17 Participants |
| Sex: Female, Male Male | 19 Participants | 33 Participants | 21 Participants | 37 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 22 | 11 / 42 | 7 / 21 | 12 / 42 |
| serious Total, serious adverse events | 1 / 22 | 1 / 42 | 0 / 21 | 2 / 42 |
Outcome results
Primary
5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Years
For patient who made it to the 5 year visit, % of patients demonstrating complete eradication of dysplasia was calculated and all were free of dysplasia
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | 5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Years | 100 percentage of participants |
| HGD:Radiofrequency Ablation | 5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Years | 96.8 percentage of participants |
Primary
5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Years
For patient who made it to the 5 year visit, % of patients demonstrating complete eradication of intestinal metaplasia (CE-IM) was calculated.
Time frame: 5 years
Population: patient who made it to the 5 year visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | 5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Years | 85.3 percentage of participants |
| HGD:Radiofrequency Ablation | 5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Years | 96.8 percentage of participants |
Primary
Durability of Eradication With no Additional Treatments
Time frame: 5 year
Population: 41 LGD subjects and 32 HGD subjects completed 5 year visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | Durability of Eradication With no Additional Treatments | 75 percentage of participants |
Primary
The % of Patients With Complete Eradication of Dysplasia at 12 Month
% of patients with complete eradication of Dysplasia out of the number of participants analyzed at 12 month was calculated.
Time frame: 12 month
Population: LGD: Radiofrequency group- 2 patients withdrew and were not analyzed, HGD: Radiofrequency Ablation: 4 patients withdrew and were not analyzed. LGD Sham procedure first then LGD Radiofrequency Ablation group and HGD Sham procedure first then HGD Radiofrequency Ablation group were not analyzed to measure the CR-D at one year.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | The % of Patients With Complete Eradication of Dysplasia at 12 Month | 95 percentage of participants |
| HGD:Radiofrequency Ablation | The % of Patients With Complete Eradication of Dysplasia at 12 Month | 89.5 percentage of participants |
Primary
The % of Patients With Complete Eradication of Intestinal Metaplasia (IM) at 12 Month
% of patients with complete eradication of IM out of the number of participants analyzed at 12 month was calculated.
Time frame: 12 month
Population: LGD: Radiofrequency group- 2 patients withdrew and were not analyzed, HGD: Radiofrequency Ablation: 4 patients withdrew and were not analyzed. LGD Sham procedure first then LGD Radiofrequency Ablation group and HGD Sham procedure first then HGD Radiofrequency Ablation group were not analyzed to measure the CR-IM at one year.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | The % of Patients With Complete Eradication of Intestinal Metaplasia (IM) at 12 Month | 85 percentage of participants |
| HGD:Radiofrequency Ablation | The % of Patients With Complete Eradication of Intestinal Metaplasia (IM) at 12 Month | 81.5 percentage of participants |
Primary
The % of Patients With Complete Histological Clearance of Intestinal Metaplasia at 24 Months.
% of patients with complete eradication of IM out of the number of participants analyzed at 24 month was calculated.
Time frame: 24 Month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | The % of Patients With Complete Histological Clearance of Intestinal Metaplasia at 24 Months. | 100 percentage of participants |
| HGD:Radiofrequency Ablation | The % of Patients With Complete Histological Clearance of Intestinal Metaplasia at 24 Months. | 97.4 percentage of participants |
| HGD Sham Procedure First Then HGD Radiofrequency Ablation | The % of Patients With Complete Histological Clearance of Intestinal Metaplasia at 24 Months. | 93.3 percentage of participants |
| HGD Radiofrequency Ablation | The % of Patients With Complete Histological Clearance of Intestinal Metaplasia at 24 Months. | 88.9 percentage of participants |
Secondary
5 Year Extension: All Cause Mortality of the Group From 2 to 5 Years.
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | 5 Year Extension: All Cause Mortality of the Group From 2 to 5 Years. | 0 percentage of participants |
Secondary
5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body After 2 Years and Inclusive of the 5 Year Visit
Time frame: 5 years
Population: Similar analysis was performed and the result is provided for the outcome measure #14. The data were collected to answer the outcome measure #14.
Secondary
5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 4 Year
Time frame: 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 4 Year | 93 percentage of participants |
Secondary
5 Year Extension:Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Year
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | 5 Year Extension:Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Year | 100 percentage of participants |
Secondary
5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 3 Year
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 3 Year | 92.9 percentage of participants |
Secondary
5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 4 Year
Time frame: 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 4 Year | 79.1 percentage of participants |
Secondary
5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Year
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Year | 85.4 percentage of participants |
Secondary
5 Year Extension: Serious Adverse Event Incidence
Time frame: 5 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LGD:Radiofrequency Ablation | 5 Year Extension: Serious Adverse Event Incidence | Bleed | 1 participants |
| LGD:Radiofrequency Ablation | 5 Year Extension: Serious Adverse Event Incidence | Chest Pain | 3 participants |
Secondary
Adverse Event Incidence
Data reported in the adverse event section
Time frame: 12 months for Treatment and Sham Comparison
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LGD:Radiofrequency Ablation | Adverse Event Incidence | AE's related to procedure | 7 Adverse event occurrences |
| LGD:Radiofrequency Ablation | Adverse Event Incidence | AE's unrelated to procedure | 17 Adverse event occurrences |
| HGD:Radiofrequency Ablation | Adverse Event Incidence | AE's related to procedure | 32 Adverse event occurrences |
| HGD:Radiofrequency Ablation | Adverse Event Incidence | AE's unrelated to procedure | 34 Adverse event occurrences |
Secondary
For 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body Since Primary RFA (0-5 Years)
Time frame: 5 years
Population: 41 LGD patients and 21 HGD subjects completed the 5 year study and used for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | For 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body Since Primary RFA (0-5 Years) | 2.7 percentage of participants |
Secondary
Histological Clearance of IM (% Biopsies)
% of patients with histological clearance of IM out of the number of participants analyzed at 12 month was calculated.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | Histological Clearance of IM (% Biopsies) | 85 percentage of participants |
| HGD:Radiofrequency Ablation | Histological Clearance of IM (% Biopsies) | 72.2 percentage of participants |
| HGD Sham Procedure First Then HGD Radiofrequency Ablation | Histological Clearance of IM (% Biopsies) | 81.5 percentage of participants |
| HGD Radiofrequency Ablation | Histological Clearance of IM (% Biopsies) | 80 percentage of participants |
Secondary
Progression of Dysplasia (i.e., HGD to Adenocarcinoma, or LGD to HGD or Adenocarcinoma)
Time frame: 5 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | Progression of Dysplasia (i.e., HGD to Adenocarcinoma, or LGD to HGD or Adenocarcinoma) | 5 participants |
| HGD:Radiofrequency Ablation | Progression of Dysplasia (i.e., HGD to Adenocarcinoma, or LGD to HGD or Adenocarcinoma) | 1 participants |
| HGD Sham Procedure First Then HGD Radiofrequency Ablation | Progression of Dysplasia (i.e., HGD to Adenocarcinoma, or LGD to HGD or Adenocarcinoma) | 1 participants |
Secondary
Quality of Life Questionnaire (Baseline v. 12 and 24 Mos)
Time frame: 0, 12, and 24 months
Population: Data had not been collected consistently to analyze the data.
Secondary
Subject Discomfort : Chest Pain Score on Day 1
Chest pain score was measured on a visual analogue scale of 0 to 100, with higher scores indicating a greater severity of pain
Time frame: Day 1 , if ablated
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| LGD:Radiofrequency Ablation | Subject Discomfort : Chest Pain Score on Day 1 | 0 Scores on a scale |
| HGD:Radiofrequency Ablation | Subject Discomfort : Chest Pain Score on Day 1 | 26 Scores on a scale |
| HGD Sham Procedure First Then HGD Radiofrequency Ablation | Subject Discomfort : Chest Pain Score on Day 1 | 0 Scores on a scale |
| HGD Radiofrequency Ablation | Subject Discomfort : Chest Pain Score on Day 1 | 22 Scores on a scale |
Secondary
The % of Patients With Complete Histological Clearance of IM at 12 Months, Comparing Treatment Versus Sham Control Groups Within a Specific Dysplasia Subgroup
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | The % of Patients With Complete Histological Clearance of IM at 12 Months, Comparing Treatment Versus Sham Control Groups Within a Specific Dysplasia Subgroup | 85 percentage of participants |
| HGD:Radiofrequency Ablation | The % of Patients With Complete Histological Clearance of IM at 12 Months, Comparing Treatment Versus Sham Control Groups Within a Specific Dysplasia Subgroup | 72.2 percentage of participants |
| HGD Sham Procedure First Then HGD Radiofrequency Ablation | The % of Patients With Complete Histological Clearance of IM at 12 Months, Comparing Treatment Versus Sham Control Groups Within a Specific Dysplasia Subgroup | 81.5 percentage of participants |
| HGD Radiofrequency Ablation | The % of Patients With Complete Histological Clearance of IM at 12 Months, Comparing Treatment Versus Sham Control Groups Within a Specific Dysplasia Subgroup | 80 percentage of participants |
Secondary
Within the HGD Subgroup, the % of Patients With Complete Histological Clearance of HGD (CR-D) at 12 Months, Comparing Treatment Versus Sham Control Groups.
Time frame: 12 Month
Population: 16 HGD Sham procedure subjects crossed over to RFA treatment after one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LGD:Radiofrequency Ablation | Within the HGD Subgroup, the % of Patients With Complete Histological Clearance of HGD (CR-D) at 12 Months, Comparing Treatment Versus Sham Control Groups. | 89.4 percentage of participants |
| HGD:Radiofrequency Ablation | Within the HGD Subgroup, the % of Patients With Complete Histological Clearance of HGD (CR-D) at 12 Months, Comparing Treatment Versus Sham Control Groups. | 86.6 percentage of participants |