NCT01961778

Brief Summary

Prospective randomized study comparing radiofrequency ablation and cryotherapy for the endoscopic treatment of Barrett's esophagus. The study is powered to assess clinical equivalence (non-inferior) of the treatment regimens.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 12, 2022

Status Verified

January 1, 2022

Enrollment Period

6 years

First QC Date

October 8, 2013

Last Update Submit

January 8, 2022

Conditions

Barrett's Esophagus

Outcome Measures

Primary Outcomes (1)

  • Percentage of Barrett's esophagus ablated during the initial treatment session.

    The primary endpoint of this study is the percentage of Barrett's esophagus ablated during the initial treatment session.

    2-3 months

Secondary Outcomes (1)

  • Patient discomfort

    2-3 days

Study Arms (2)

Radio-Frequency Ablation

ACTIVE COMPARATOR

Patients in this arm will receive treatment with radio-frequency ablation.

Device: Radio-Frequency Ablation

Cryothearpy

ACTIVE COMPARATOR

Patients in this arm will receive treatment with cryotherapy.

Device: Cryotherapy

Interventions

Radio-Frequency AblationDEVICE
Also known as: Barrx
Radio-Frequency Ablation
CryotherapyDEVICE
Also known as: Trufreeze, CSA Medical
Cryothearpy

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • suitable candidates for endoscopic treatment of Barrett's esophagus (BE) with high-grade dysplasia (HGD) and/or early adenocarcinoma of the esophagus

You may not qualify if:

  • contraindications to endoscopic treatment (e.g., bleeding diathesis, pregnancy, severe medical comorbidities, advanced liver disease)
  • refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Radiofrequency AblationCryotherapy

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Norman S Nishioka, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 11, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2019

Study Completion

February 1, 2020

Last Updated

January 12, 2022

Record last verified: 2022-01

Locations

US(1)