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CLEANS Technique for the Treatment of Esophageal Food Impaction

NCT03570567 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-06-27

No results posted yet for this study

Summary

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.

Conditions

  • Esophageal Food Impaction

Interventions

DEVICE

Piranha Treatment

The piranha device is used with an endoscope to breakup/dislodge the food bolus.

Sponsors & Collaborators

  • Biomerics, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2018-09-30
Completion
2018-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03570567 on ClinicalTrials.gov