A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With trūFreeze™ Spray Cryotherapy — DOSE  

Barrett's Esophagus Clinical Trial

Official title: A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With trūFreeze™ Spray Cryotherapy ("DOSE" Trial)

Status Terminated

Clinical Trial Summary

The primary objective of this study is to determine the percentage segment regression after spray cryotherapy in a dose-escalation study performed in patients with dysplastic Barrett's Esophagus (BE) using trūFreeze™ spray cryotherapy within the currently recommended therapeutic range.

Secondary objectives are the determination of safety related outcomes such as esophageal stricture.

Clinical Trial Description

This is an adaptive dose-escalation clinical trial using trūFreeze™ spray cryotherapy for the treatment of dysplastic Barrett's Esophagus in a clinical setting.

Participants will be enrolled in cohorts of up to 15. Each cohort will receive a similarly dosed spray cryotherapy treatment, based on outcomes from the previous cohort. Participants will receive one treatment with spray cryotherapy per the protocol and will then be followed clinically. During the next scheduled clinical endoscopy, participants will be assessed for percent regression of disease following the spray cryotherapy treatment. A determination will be made regarding effectiveness of each dose based on the number of subjects that achieve the primary outcome criterion (>= 50 percent BE segment regression).

The first cohort of up to 15 participants will receive an upper endoscopy in which systematic images of the esophagus will be taken for the research study and will then receive a treatment with spray cryotherapy using the trūFreeze™ system. These participants will have a clinical follow-up endoscopy scheduled approximately 2 months after the initial spray cryotherapy procedure. During the follow-up endoscopy, physicians will be asked to provide an estimate of the percent regression of disease as well as systematic images of the esophagus. These images will be sent to a central panel of masked experts who will assess percent regression of disease compared to images taken prior to the first ablation procedure.

Interim reviews of potential dose effectiveness will occur when 7 and 11 participants have completed the follow-up visit. If during an interim review at least 5 participants experience a sub-therapeutic response, the dose will be considered sub-therapeutic as not meeting the definition of "fully effective," the cohort will be closed to new enrollment, and enrollment on a new cohort at the next higher dose will begin. If during an interim review less than 5 participants experience a sub-therapeutic response, enrollment on that cohort will continue.

If/when enrollment on a cohort reaches 15 participants a decision will be made regarding the effectiveness of the dose. If a dose is found to be "ineffective" or "partially effective," then a new cohort of individuals will be enrolled at a prescribed higher starting dose. If a dose is found to be "fully effective," then a confirmatory cohort will be enrolled at the same dose to confirm results. Enrollment will continue until a "fully effective" therapeutic dose of spray cryotherapy is identified and confirmed in two cohorts of 15 participants each. ;

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

• NCT number: NCT01845454
• Study type: Interventional
• Source: CSA Medical, Inc.
• Status: Terminated
• Phase: N/A
• Start date: April 2013
• Completion date: January 2015