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

N/AEnrolling By InvitationNCT03311451

Pentax Medical30 enrolled

Overview

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.

The procedure will be performed on an outpatient basis, and the CryoBalloon 180 Ablation system will be used for all ablations following the instructions for use provided with the product. Patients who meet the eligibility criteria will be assigned to one of the treatment groups and doses, depending on the order of their enrollment: In phase I, the first 25 patients will be treated with Dose 1 (lowest), in one application to ablate 50% of the esophageal circumference. All patients will undergo 10 week (±2 weeks) follow-up EGD to evaluate efficacy of the dose before the study continues. If follow-up shows that Dose 1 eradicates ≤60% of the treated BE (by median percentage) and no SAE's are reported, the treatment phase will continue but at the next incremental higer dose (Second Dose) after approval from the IRB. If the Dose 1 median BE surface regression percentage is ≥60%, the dose is defined as the therapeutic dose. In that case, an additional group of 25 patients will be enrolled at this dose, pending IRB approval. \--------------------------------------------------------------- Dose-related SAEs include pain in the treatment area greater than 6 (0-10 VAS score) at 24 hours AND seven (7) days post-treatment; symptomatic stricture requiring an additional EGD with endoscopic dilation before the first follow-up EGD; symptomatic stricture at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the therapeutic endoscope at follow-up EGD. Any other serious adverse events within 30 days after treatment will also be evaluated by the Data and Safety Monitoring Board (DSMB) for relationship to the dose and severity. When a Dose-related serious adverse event occurs, the Holding Rule will be invoked and enrollment at that dose will be held until the DSMB has evaluated the event.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Barrett Esophagus

Interventions

C2 CryoBalloon 180° Ablation SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 2. Prague Classification Score C≤3 and ≥M1 3. Patients should be ablation-naïve (no previous ablation therapy of the esophagus) 4. Older than 18 years of age at time of consent 5. Operable per institution's standards 6. Patient provides written informed consent on the IRB-approved informed consent form 7. Patient is willing and able to comply with follow-up requirements. Exclusion Criteria: 1. Esophageal stenosis preventing advancement of a therapeutic endoscope 2. 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. 3. Prior ER of more than 2cm in length or \>50% of the esophageal lumen circumference 4. History of locally advanced (\>SM1) esophageal cancer 5. History of esophageal varices 6. Prior distal esophagectomy 7. Active esophagitis LA grade B or higher 8. Severe medical comorbidities precluding endoscopy 9. Uncontrolled coagulopathy 10. Pregnant or planning to become pregnant during period of study 11. Patient refuses or is unable to provide written informed consent 12. Participation in another study with investigational drug within the 30 days preceding or during the present study, interfering with participation in the current study 13. General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation

Locations (5)

AMC Medical Research B.V.

Amsterdam, Netherlands

UMC Groningen

Groningen, Netherlands

St. Antonius Hospital

Nieuwegein, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

UMC Utrecht

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: 30 days

Secondary Outcomes

Incidence of AEs

Incidence of all serious and non-serious adverse events up to 30 days post-treatment

Time frame: 30 days

Patient reported post-procedure pain

Post-procedure pain in the area of the cryoablation treatment (0-10 VAS score)

Time frame: 24hours and 7 days post-procedure

Efficacy: Percent Regression

Efficacy, defined as the regression percentage at the first follow-up endoscopy, after one (1) treatment covering 50% of circumference of the esophagus with the therapeutic dose.

Time frame: 10 weeks

Efficacy: Treatment

Efficacy of treatment with CryoBalloon 180 Ablation system, defined as the proportion of patients with ≥80% regression of BE after 1 hemi-circumferential and after full circumferential treatment.

Time frame: 10 weeks

Data from ClinicalTrials.gov

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