C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.

NCT03311451 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: CP-0019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

The primary objective is to determine the safety, performance and efficacy of the C2 CryoBalloon 180 Ablation System ("CryoBalloon 180") used at decreasing doses in treatment naïve patients with low- or high-grade dysplastic Barrett's Esophagus (BE) or with residual BE after resection of dysplasia or early adenocarcinoma.

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (2)

• Efficacy: Dose response

  Dose response (efficacy) is defined as eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose (phase II).

  10 weeks

• Safety: Incidence of 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

Secondary Outcomes (4)

• Incidence of AEs

  30 days

• Patient reported post-procedure pain

  24hours and 7 days post-procedure

• Efficacy: Percent Regression

  10 weeks

• Efficacy: Treatment

  10 weeks

Study Arms (1)

C2 CryoBalloon 180 Ablation System

OTHER

C2 CryoBalloon 180 Ablation System will be used to ablate visible Barrett's esophagus

Device: C2 CryoBalloon 180° Ablation System

Interventions

C2 CryoBalloon 180° Ablation System DEVICE

The C2 CryoBalloon 180° Ablation System is a cryosurgical device with a nitrous oxide cooled balloon probe that is compatible with upper gastrointestinal therapeutic endoscopes.

Also known as: CryoBalloon 180

C2 CryoBalloon 180 Ablation System

Eligibility Criteria

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

You may qualify if:

• Patients with flat- type BE esophagus, with an indication for ablation therapy, defined as:
• Diagnosis of LGD or HGD in BE (confirmed by central pathology review), OR
• Residual BE with any grade of dysplasia 6 weeks after endoscopic resection
• Prague Classification Score C≤3 and ≥M1
• Patients should be ablation-naïve (no previous ablation therapy of the esophagus)
• Older than 18 years of age at time of consent
• Operable per institution's standards
• Patient provides written informed consent on the IRB-approved informed consent form
• Patient is willing and able to comply with follow-up requirements.

You may not qualify if:

• Esophageal stenosis preventing advancement of a therapeutic endoscope
• Any endoscopically visualized lesion such as ulcers, masses or nodules. Neoplastic nodules must first be treated with ER \>6 weeks prior to planned treatment under this protocol.
• Prior ER of more than 2cm in length or \>50% of the esophageal lumen circumference
• History of locally advanced (\>SM1) 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, interfering with participation in the current study
• General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation

Sponsors & Collaborators

• Pentax Medical: lead

Study Sites (5)

AMC Medical Research B.V.

Amsterdam, Netherlands

Location

UMC Groningen

Groningen, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Bas LA Weusten, MD, PhD

  St. Antonius Ziekenhuis, Niewegein The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Patients with previously untreated (by means of ablation therapy) flat type Barrett's Esophagus (BE) (extent BE ≤C3 and ≥M1) with Low-Grade Dysplasia (LGD) or High-Grade Dysplasia (HGD), or residual BE after endoscopic resection of dysplasia or early adenocarcinoma.

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 17, 2017
• Study Start: January 16, 2023
• Primary Completion: August 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (5)