CBAS180 De-escalation Study

NCT05740189 | Recruiting DMC FDA Device

• 1 other identifier: NL73252.000.22
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 6

Brief Summary

Evaluate the efficacy and safety of the C2 CryoBalloon 180° Ablatie Systeem (CBAS180) at decremental doses for the treatment of dysplastic Barrett's epithelium.

Conditions

Barrett's Esophagus; Ablation Therapy; Cryotherapy; Cryoballoon Ablation

Outcome Measures

Primary Outcomes (4)

• Efficacy: Dose response

  Efficacy (dose response) will be evaluated by the BE surface regression percentage after 1 circumferential treatment session, as evaluated by the EGD-Adjudication Committee (EGD-AC) and confirmed by histological evidence of eradication of BE.

  3 months

• 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 greater than 6 (scored on a 0 to 10-point numeric rating scale (NRS)) at 24 hours post-treatment; symptomatic stricture requiring an additional EGD plus endoscopic dilation before first follow-up EGD; symptomatic stricture requiring endoscopic dilation at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.

  24hours

• 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 greater than 6 (scored on a 0 to 10-point numeric rating scale (NRS)) at 7 days post-treatment; symptomatic stricture requiring an additional EGD plus endoscopic dilation before first follow-up EGD; symptomatic stricture requiring endoscopic dilation at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.

  7 days

• 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 greater than 6 (scored on a 0 to 10-point numeric rating scale (NRS)) at 30 days post-treatment; symptomatic stricture requiring an additional EGD plus endoscopic dilation before first follow-up EGD; symptomatic stricture requiring endoscopic dilation at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.

  30 days

Secondary Outcomes (11)

• Feasibility: technical succes

  Directly after procedure

• Post-procedural pain

  Directly after procedure

• Post-procedural pain

  24 hours

• Post-procedural pain

  7 days

• Post-procedural pain

  30 days

Study Arms (1)

C2 CryoBalloon 180 Ablation System

EXPERIMENTAL

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.

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:

• Flat type BE esophagus, with an indication for ablation therapy, defined as:
• Diagnosis of LGD or HGD in BE (confirmed by BE expert pathologist) or;
• Residual BE with any grade of dysplasia after endoscopic resection (by means of EMR or ESD) to treat non-flat BE, ≥6 weeks prior to enrolling the patient to this study. The ER pathology should indicate endoscopic treatment (i.e. only mucosal invasion or limited submucosal invasion (sm1), no lymphovascular infiltration, free vertical resection margins and not poorly differentiated).
• Prague Classification Score of C≤3 and M≥1.
• Patients should be ablation-naïve, meaning they have not undergone any previous endoscopic ablation therapy of the esophagus.
• Older than 18 years of age at time of consent.
• Fit for endoscopic therapy 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 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 \>2cm in length and/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.

Sponsors & Collaborators

• Koen Munters: lead
• Pentax Medical: collaborator

Study Sites (6)

Catharina Hospital

Eindhoven, North Brabant, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, North Holland, Netherlands

RECRUITING

UMC Groningen

Groningen, Provincie Groningen, Netherlands

RECRUITING

Erasmus MC

Rotterdam, South Holland, Netherlands

RECRUITING

St Antonius hospital

Nieuwegein, Utrecht, Netherlands

RECRUITING

UMC Utrecht

Utrecht, Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Koen Munters, Msc

CONTACT

088-7559682; k.munters-3@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Fellow, MD, Gastroenterology and Hepatology

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 22, 2023
• Study Start: February 19, 2023
• Primary Completion: May 31, 2025
• Study Completion: January 15, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

NL (6)