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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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.


Detailed Summary:

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 def
Sponsor: CSA Medical, Inc.

Current Primary Outcome: Efficacy of Spray Cryotherapy Dose: Percent Regression of Disease Following Baseline Spray Cryotherapy [ Time Frame: Next follow-up endoscopy scheduled as routine care (2 months +/- 4 weeks) ]

Percent regression of disease will be used to determine efficacy of spray cryotherapy dose used. If at follow-up there is less than a 50% reduction in Barrett's Esophagus, the outcome will be characterized as sub-therapeutic for that participant. If a 50% or greater reduction is seen then this would be characterized as therapeutic. In each cohort of 15:

  • If less than 5 subjects are found to have a "therapeutic" response , dose = "ineffective"
  • If 5 to 10 subjects are found to have a "therapeutic" response, dose = "partially effective"
  • If 11 to 15 subjects have a "therapeutic" response, dose = "fully effective"

If a dose is found to be "ineffective" or "partially effective", then a new evaluation cohort of 15 individuals will be enrolled on the next higher dose. If the dose is considered "fully effective" then a second cohort of 15 individuals will be enrolled on the same dose to confirm. Enrollment continues until a fully effective dose is attained and confirmed



Original Primary Outcome: Same as current

Current Secondary Outcome: Safety Outcomes [ Time Frame: Next follow-up endoscopy scheduled as routine care (2 months +/- 4 weeks) ]

Secondary objectives are the determination of safety related outcomes such as esophageal stricture and will be captured by reportable events.


Original Secondary Outcome: Same as current

Information By: CSA Medical, Inc.

Dates:
Date Received: April 25, 2013
Date Started: April 2013
Date Completion:
Last Updated: April 27, 2016
Last Verified: April 2016