Trial Outcomes & Findings for HALO Patient Registry: Ablation of Barrett's Esophagus (NCT NCT00848237)

NCT ID: NCT00848237

Last Updated: 2016-02-05

Results Overview

% 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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 5521 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2016-02-05

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	5521
Overall Study COMPLETED	4982
Overall Study NOT COMPLETED	539

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HALO Patient Registry: Ablation of Barrett's Esophagus

Baseline characteristics by cohort

Measure	Treatment n=5521 Participants 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.
Age, Categorical <=18 years	1 participants n=5 Participants
Age, Categorical Between 18 and 65 years	3235 participants n=5 Participants
Age, Categorical >=65 years	2279 participants n=5 Participants
Age, Continuous	61.6 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	1469 Participants n=5 Participants
Sex: Female, Male Male	4052 Participants n=5 Participants
Region of Enrollment United States	5521 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: 4011 subjects provided the answers

% 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.

Outcome measures

Measure

Treatment n=4011 Participants 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.

Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up

62.1 percentage of participants

PRIMARY outcome

Timeframe: 1 year

Population: 4118 provided biopsies at least 1 year post RFA

Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up

Outcome measures

Measure

Treatment n=4118 Participants 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.

Histological Clearance Rate for Intestinal Metaplasia (CE-IM)

85.5 percentage of participants

PRIMARY outcome

Timeframe: 1 year

Population: 4118 provided biopsies at least 1 year post RFA and non dysplasia subjects from 4118 were removed for CE-D analysis

percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up

Outcome measures

Measure

Treatment n=2224 Participants 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.

Histological Clearance Rate for Dysplasia (CE-D)

93.5 percentage of participants

PRIMARY outcome

Timeframe: 1 year

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

Outcome measures

Measure

Treatment n=5521 Participants 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.

Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up

2.7 percentage of patients with SSIM

PRIMARY outcome

Timeframe: 12 month

Population: 943 subjects completed both baseline and follow up quality of life life survey

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).

Outcome measures

Measure	Treatment n=943 Participants 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.
Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month Changes:concern about the condition of esophagus	-2.7 units on a scale Standard Deviation 3.2
Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month Negative impact on life	-1.9 units on a scale Standard Deviation 3.0
Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month Esophageal cancer worry	-2.8 units on a scale Standard Deviation 3.4

PRIMARY outcome

Timeframe: 12 month

Adverse and Serious Adverse event with Definite device relationship

Outcome measures

Measure

Treatment n=5521 Participants 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.

Adverse Event Incidence

66 participants

Adverse Events

Treatment

Serious events: 24 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=5521 participants at risk 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.
Injury, poisoning and procedural complications Pain, Nausea, vomitting, fullness, abdominal discomfort	0.11% 6/5521
Injury, poisoning and procedural complications Dysphagia and/or Odynophagia	0.04% 2/5521
Injury, poisoning and procedural complications aspiration	0.02% 1/5521
Injury, poisoning and procedural complications Dysphagia/Upper GI Bleed	0.02% 1/5521
Injury, poisoning and procedural complications Esophageal spasms	0.02% 1/5521
Injury, poisoning and procedural complications Esophagitis and/or Ulceration	0.04% 2/5521
Injury, poisoning and procedural complications Fever	0.04% 2/5521
Injury, poisoning and procedural complications Hematemesis	0.02% 1/5521
Injury, poisoning and procedural complications Melena	0.05% 3/5521
Injury, poisoning and procedural complications Mucosal Tear / Laceration	0.02% 1/5521
Injury, poisoning and procedural complications Perforation	0.02% 1/5521
Injury, poisoning and procedural complications Stricture and/or dysphagia requiring dilatation	0.04% 2/5521
Injury, poisoning and procedural complications Upper GI Bleeding	0.04% 2/5521

Other adverse events

Measure	Treatment n=5521 participants at risk 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.
Injury, poisoning and procedural complications Catheter interaction with existing sutures	0.02% 1/5521
Injury, poisoning and procedural complications Dysphagia and/or Odynophagia	0.07% 4/5521
Injury, poisoning and procedural complications Esophageal spasms	0.02% 1/5521
Injury, poisoning and procedural complications Esophagitis and/or Ulceration	0.07% 4/5521
Injury, poisoning and procedural complications Hematemesis	0.02% 1/5521
Injury, poisoning and procedural complications Mallory-weiss tear	0.02% 1/5521
Injury, poisoning and procedural complications Mucosal Tear / Laceration	0.25% 14/5521
Injury, poisoning and procedural complications Mucosal trauma	0.02% 1/5521
Injury, poisoning and procedural complications Oxygen desaturation	0.02% 1/5521
Injury, poisoning and procedural complications Pain, Nausea, vomitting, fullness, abdominal discomfort	0.22% 12/5521
Injury, poisoning and procedural complications Prior Stricture worsen by RFA	0.02% 1/5521
Injury, poisoning and procedural complications Sizing Balloon did not work	0.02% 1/5521
Injury, poisoning and procedural complications Stricture - no dilatation	0.22% 12/5521
Injury, poisoning and procedural complications Stricture and/or dysphagia requiring dilatation	0.67% 37/5521
Injury, poisoning and procedural complications Stricture requiring dilatation- History EMR or Stricture	0.04% 2/5521
Injury, poisoning and procedural complications Upper GI Bleeding	0.09% 5/5521

Additional Information

Nicholas Shaheen

University of north Carolina

Phone: (919) 966-7047

Email: nshaheen@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60