NCT03097666

Brief Summary

The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe Ablation System ("CryoBalloon Swipe") used at increasing doses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

3 active sites

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

March 1, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

March 20, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

1.6 years

First QC Date

March 1, 2017

Last Update Submit

April 21, 2022

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (2)

  • Dose-related SAEs

    Safety will be evaluated by the incidence of Dose-related SAEs. Dose-related SAEs include pain in the treatment area, or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.

    30 days

  • Efficacy: Percent Eradication by therapeutic dose

    Eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.

    8 weeks

Secondary Outcomes (4)

  • Incidence of AEs

    up to 30 days post-treatment

  • Post-procedure pain

    24 hours and 7 days post-procedure

  • Efficacy: Percent Regression

    8 weeks

  • Efficacy: Treatment

    8 weeks

Study Arms (1)

C2 Cryoballoon Swipe Ablation System

OTHER

C2 Cryoballoon Swipe Ablation System

Device: C2 CRYOBALLOON SWIPE ABLATION SYSTEM

Interventions

C2 CRYOBALLOON SWIPE ABLATION SYSTEMDEVICE

The C2 CryoBalloon Swipe Ablation System ("CryoBalloon Swipe") is a cryosurgical device with a nitrous oxide cooled balloon probe that is compatible with upper gastrointestinal diagnostic endoscopes.

C2 Cryoballoon Swipe Ablation System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with flat-type (Paris type 0-IIb) BE esophagus, with an indication for ablation therapy, meaning:
  • Diagnosis of LGD or HGD in BE (confirmed by baseline histopathological analysis), OR
  • Residual BE with any grade of dysplasia after endoscopic resection
  • Prague Classification Score C≤3
  • Patients should be ablative-naïve (no previous ablation therapy of the esophagus)
  • Older than 18 years of age at time of consent
  • Operable per institution's standards
  • Provides written informed consent on the IRB-approved informed consent form
  • Willing and able to comply with follow-up requirements

You may not qualify if:

  • Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope.
  • Any endoscopically visualized lesion such as ulcers, masses or nodules.
  • History of locally advanced (\>T1a) esophageal cancer
  • History of esophageal varices
  • Prior distal esophagectomy
  • Active esophagitis LA grade B or higher
  • Severe medical comorbidities precluding endoscopy
  • Uncontrolled coagulopathy
  • Pregnant or planning to become pregnant during period of study
  • Patient refuses or is unable to provide written informed consent
  • Participation in another study with investigational drug within the 30 days preceding or during the present study
  • General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

AMC Medical Research B.V.

Amsterdam, Netherlands

Location

St. Antonius Hospital Nieuwegein

Amsterdam, Netherlands

Location

Catharina Ziekenhuis te Eindhoven

Eindhoven, Netherlands

Location

Related Publications (1)

  • Sunakawa H, Yoda Y, Nonaka S, Suzuki H, Abe S, Ishiguro Y, Ikeno T, Wakabayashi M, Sato A, Nakajo K, Kadota T, Yano T. Prospective multicenter trial of the cryoballoon ablation system for superficial esophageal squamous cell carcinoma on post-endoscopic resection scars: a CRYO-SCAR study (EPOC1902). Gastrointest Endosc. 2024 Sep;100(3):429-437. doi: 10.1016/j.gie.2024.02.018. Epub 2024 Feb 29.

    PMID: 38431103DERIVED

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients with previously untreated (by means of ablation therapy) flat type Barrett's Esophagus (BE) (extent BE ≤C3) with Low-Grade Dysplasia (LGD) or High-Grade Dysplasia (HGD), or residual BE after removal of early adenocarcinoma
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 31, 2017

Study Start

March 20, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Data will not be shared.

Locations

NL(3)