CLEANS Technique for the Treatment of Esophageal Food Impaction

Clinical Luminal Endoscopic Assessment of a Novel Suction (CLEANS) Technique for the Treatment of Esophageal Food Impaction

This clinical investigation is to evaluate the safety, performance, and efficacy of a novel endoscopic technique for resolving esophageal food impactions by using a novel hollow suction catheter, Piranha GI Aspiration Catheter, to core out and suction food away from the center of an impaction. This technique includes hollowing out the center of the impaction, thus reducing the volume of the food bolus in the center, allowing the food to collapse into the hollow center, and then allowing for spontaneous food passage into the stomach. The study design is based on the experience of the investigators and the general knowledge of the food impaction field. In addition, consideration was given to previous studies of endoscopic treatments for esophageal food impaction.

CLEANS Synopsis Protocol Number 001 Procedure/Device Endoscopy using a standard suction catheter Sponsor Biomerics Advanced Catheter Primary Objective The objective of the trial is to evaluate the efficacy of a novel coring/suctioning technique for esophageal food impactions using a suction catheter. Data obtained from this clinical trial will be used to support this technique for standard clinical use.

Proposed Use Esophageal food impactions. Study Design This is a single-arm, open label observational trial designed to assess the efficacy of a novel suction technique for the treatment of esophageal food impactions. The endoscopists performing the procedure are not blinded to the treatment.

Follow-Up Schedule There is no follow-up after the procedure. Number of Subjects/Sites 40 non-randomized subjects, 10 at 4 investigational sites.

Exclusion Criteria

1. Unable to tolerate an endoscopic procedure.
2. Has a condition that could lead to significant postoperative complications, including current infection, anticoagulant use (Note: this is a relative exclusion since these patients still may require endoscopic food clearance).
3. Enrolled in a concurrent clinical food impaction trial.
4. Inability to comply with the consent process (as determined by investigator).
5. Pregnant.

Statistical Methods Statistical Methods were developed based on the Safety Primary Endpoint.

A sample size of 40 (10 at each site) achieves 80% power to detect a safety non-inferiority difference of 0.1322 using a one-sided exact test with a significance level (alpha) of 0.05. These results assume a baseline adverse event proportion of 0.03. The non-inferiority difference is justified by the low risk nature of the procedure.

The sample size achieves 80% power to detect a performance non-inferiority difference of -0.1837 using a one-sided exact test with a significance level (alpha) of 0.05. These results assume a baseline bolus clearance proportion of 0.75. The non-inferiority difference is justified by the low risk nature of the procedure.

Efficacy/performance procedure time endpoint will be assessed with time distribution analysis and with linear regression techniques using clinician, site, type of impaction, cause, age, gender, and weight as factors. Other factors may be included.

Efficacy/performance secondary endpoints will be assessed with score distribution analysis and with linear regression techniques using clinician, site, type of impaction, cause, age, gender, and weight as factors. Other factors may be included.

Sample size requirements 40 patients, 10 patients at each site. Analysis cohorts All patients who undergo endoscopy for a food impaction. Safety Assessments Adverse events will be summarized by seriousness, severity, relationship to device and procedure and adverse event type.

Additional Analyses None intended at this time. Randomization Patients will not be randomized. Blinding Neither subjects nor endoscopists will be blinded to the study treatment.

Study Duration The study participation will end following the procedure.

Inclusion Criteria:

• Esophageal food impaction requiring endoscopic intervention.
• Male or female.
• Age 18-85.
• Willing to participate and capable of understanding the clinical study procedure and giving informed consent.

Exclusion Criteria:

• Unable to tolerate an endoscopic procedure.
• Has a condition that could lead to significant postoperative complications, including current infection, anticoagulant use (Note: this is a relative exclusion since these patients still may require endoscopic food clearance).
• Enrolled in a concurrent clinical food impaction trial.
• Inability to comply with the consent process (as determined by investigator).
• Pregnant.