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