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The HALO Patient Registry is a prospective/retrospective, multi-center patient registry. It provides a framework for treatment and follow-up of patients with Barrett's esophagus (non-dysplastic IM, LGD and HGD). The primary objective is to provide a tool for participating physician investigators to collect outcomes data related to the use of the HALO Ablation Systems.
Summary The HALO Patient Registry provides a framework for treatment and follow-up of patients with Barrett's esophagus (non-dysplastic IM, LGD and HGD). The primary objective is to provide a tool for participating physician investigators to collect outcomes data related to the use of the HALO Ablation Systems.
Protocol Design:
This is a prospective, multi-center patient Registry. Sites may choose to also retrospectively enroll previously treated patients (after obtaining informed consent) and enter retrospective data into case report forms on-line. "Retrospective data collection" is defined as any data other than patient history collected prior to signing of the informed consent. A set of case report forms (CRFs) is provided along with this protocol to track outcomes. The CRFs may be completed and retained on site, but the site is recommended to utilize the internet-based data entry system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Ablation (HALO Ablation Systems) | Device | Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy. |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up | % of patients with 100 % resolution at 1 year follow-up. This endpoint is a visual and not reliable or accurate. A better measure of clearance of Barrett's esophagus is based on biopsies. | 1 year |
| Histological Clearance Rate for Intestinal Metaplasia (CE-IM) | Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up | 1 year |
| Histological Clearance Rate for Dysplasia (CE-D) | percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up | 1 year |
| Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up | Percentage of patients at 1 year follow-up with sub-squamous intestinal metaplasia, with or without dysplasia, that is covered completely by an intact layer of squamous epithelium with no communication with the surface | 1 year |
| Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month | Patient who completed both baseline and follow-up Quality of Life: Scores (0-10) of quality of life at baseline and 12 month follow-up were measured and changes were calculated ( 12 months minus baseline) in: concerns about the condition of esophagus, negative impact on life and esophageal cancer worry. Scale range is 0-10, 0 is min and 10 is max. Higher value represent worse outcome (such as higher concern about the condition of esophagus, negative impact on life and higher esophageal cancer worry). | 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas J Shaheen, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastrointestinal Associates and sites across the US | Knoxville and Other US Cities | California | 27599-7080 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22965650 | Result | Shaheen NJ, Kim HP, Bulsiewicz WJ, Lyday WD, Triadafilopoulos G, Wolfsen HC, Komanduri S, Chmielewski GW, Ertan A, Corbett FS, Camara DS, Rothstein RI, Overholt BF. Prior fundoplication does not improve safety or efficacy outcomes of radiofrequency ablation: results from the U.S. RFA Registry. J Gastrointest Surg. 2013 Jan;17(1):21-8; discussion p.28-9. doi: 10.1007/s11605-012-2001-8. Epub 2012 Sep 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system. Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system. Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Note: 6 subjects: Age unknown |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up | % of patients with 100 % resolution at 1 year follow-up. This endpoint is a visual and not reliable or accurate. A better measure of clearance of Barrett's esophagus is based on biopsies. | 4011 subjects provided the answers | Posted | Number | percentage of participants | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system. Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain, Nausea, vomitting, fullness, abdominal discomfort | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter interaction with existing sutures | Injury, poisoning and procedural complications | Non-systematic Assessment |
Endoscopic clearance rate for Barrett's esophagus-Percentage of patients with no endoscopically visible Barrett's esophagus at 1 year follow-up: This endpoint is a visual and not reliable or accurate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicholas Shaheen | University of north Carolina | (919) 966-7047 | nshaheen@med.unc.edu |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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|
|
| Adverse Event Incidence |
Adverse and Serious Adverse event with Definite device relationship |
| 12 month |
| Number |
| participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Histological Clearance Rate for Intestinal Metaplasia (CE-IM) | Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up | 4118 provided biopsies at least 1 year post RFA | Posted | Number | percentage of participants | 1 year |
|
|
|
| Primary | Histological Clearance Rate for Dysplasia (CE-D) | percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up | 4118 provided biopsies at least 1 year post RFA and non dysplasia subjects from 4118 were removed for CE-D analysis | Posted | Number | percentage of participants | 1 year |
|
|
|
| Primary | Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up | Percentage of patients at 1 year follow-up with sub-squamous intestinal metaplasia, with or without dysplasia, that is covered completely by an intact layer of squamous epithelium with no communication with the surface | Posted | Number | percentage of patients with SSIM | 1 year |
|
|
|
| Primary | Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month | Patient who completed both baseline and follow-up Quality of Life: Scores (0-10) of quality of life at baseline and 12 month follow-up were measured and changes were calculated ( 12 months minus baseline) in: concerns about the condition of esophagus, negative impact on life and esophageal cancer worry. Scale range is 0-10, 0 is min and 10 is max. Higher value represent worse outcome (such as higher concern about the condition of esophagus, negative impact on life and higher esophageal cancer worry). | 943 subjects completed both baseline and follow up quality of life life survey | Posted | Mean | Standard Deviation | units on a scale | 12 month |
|
|
|
| Primary | Adverse Event Incidence | Adverse and Serious Adverse event with Definite device relationship | Posted | Number | participants | 12 month |
|
|
|
| 24 |
| 5,521 |
| 42 |
| 5,521 |
| Dysphagia and/or Odynophagia | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| aspiration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Dysphagia/Upper GI Bleed | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Esophageal spasms | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Esophagitis and/or Ulceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fever | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hematemesis | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Melena | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Mucosal Tear / Laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Perforation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Stricture and/or dysphagia requiring dilatation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Upper GI Bleeding | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Dysphagia and/or Odynophagia | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Esophageal spasms | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Esophagitis and/or Ulceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hematemesis | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Mallory-weiss tear | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Mucosal Tear / Laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Mucosal trauma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Oxygen desaturation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Pain, Nausea, vomitting, fullness, abdominal discomfort | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Prior Stricture worsen by RFA | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Sizing Balloon did not work | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Stricture - no dilatation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Stricture and/or dysphagia requiring dilatation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Stricture requiring dilatation- History EMR or Stricture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Upper GI Bleeding | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
|