Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium

NCT02534233 | Completed Results DMC FDA Device

• 1 other identifier: NA_00075654
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Assess Cryoablation (CryoBalloon Ablation cryotherapy) for treatment of Dysplastic Barrett's Esophagus, Esophageal Squamous Dysplasia and early Esophageal Cancer. The cryoablation treatment will be offered as an alternative to standard ablation therapies such as Radiofrequency Ablation, Argon Plasma Coagulation and carbon dioxide Cryotherapy).

Conditions

Barrett's Esophagus; Esophageal Squamous Dysplasia; Esophageal Cancer

Keywords

barrett's esophagus with dysplasia; early esophageal cancer

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Complete Eradication of Esophageal Dysplasia

  Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus or squamous dysplasia after cryoablation treatments (assess for complete eradication of dysplasia).

  12 months

• Treatment-related Adverse Events Assessed by Pain Scale

  Evaluate by patient questionnaire for pain on an 11-point scale. The 11-point Likert scale represents a range of discomfort or pain from 0 (no pain) to 10 (extreme pain), which individuals indicate their level of discomfort or pain. Higher score more discomfort. Each subject is evaluated for post-treatment pain after each cryoablation session. Subjects may have a different number of treatment sessions depending on the extent of disease.

  1 day post treatment (day 2), 1 week post treatment (day 8), and 1 month (day 31)

• Treatment-related Adverse Events Assessed by Stricture Rate

  Number of patients with esophageal strictures requiring dilation. Patients reporting dysphagia with solid food, with balloon dilations from index visit to 12 months.

  Up to 12 months

Secondary Outcomes (1)

• Number of Participants With Complete Eradication of Intestinal Metaplasia

  12 months

Study Arms (1)

CryoBalloon ablation

EXPERIMENTAL

Patients having ablation of dysplastic tissue in esophagus.

Device: CryoBalloon

Interventions

CryoBalloon DEVICE

Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter

Also known as: Cryoablation

CryoBalloon ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients recommended for ablation of either Barrett's esophagus with dysplasia or esophageal squamous dysplasia, scheduled for upper endoscopy.

You may not qualify if:

• Patient unable to undergo endoscopy,
• Patients with visible esophageal mass.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Pentax Medical: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Canto MI, Shaheen NJ, Almario JA, Voltaggio L, Montgomery E, Lightdale CJ. Multifocal nitrous oxide cryoballoon ablation with or without EMR for treatment of neoplastic Barrett's esophagus (with video). Gastrointest Endosc. 2018 Sep;88(3):438-446.e2. doi: 10.1016/j.gie.2018.03.024. Epub 2018 Apr 5.

  PMID: 29626424 RESULT

• Canto MI, Abrams JA, Kunzli HT, Weusten B, Komatsu Y, Jobe BA, Lightdale CJ. Nitrous oxide cryotherapy for treatment of esophageal squamous cell neoplasia: initial multicenter international experience with a novel portable cryoballoon ablation system (with video). Gastrointest Endosc. 2018 Feb;87(2):574-581. doi: 10.1016/j.gie.2017.07.013. Epub 2017 Jul 16.

  PMID: 28720474 RESULT

Related Links

• Durability of Cryoballoon Ablation in Neoplastic Barrett's Esophagus

MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

Prospective single arm non-randomized trial, no control subjects.

Results Point of Contact

• Title: Dr Marcia Canto, Director of Clinical Research
• Organization: Johns Hopkins Hospital

mcanto1@jhmi.edu

443-287-8083

Study Officials

• Marcia Canto, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 27, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2024
• Study Completion: February 27, 2025
• Last Updated: August 1, 2025
• Results First Posted: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)