CLEANS Technique for the Treatment of Esophageal Food Impaction
Status unconfirmed · Not applicable
Conditions studied: Esophageal Food Impaction
In brief
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.
Key facts
- Study ID
- NCT03570567
- Run by
- Biomerics, LLC
- People needed
- 40
- Starts
- 2018-06-01
- Expected to finish
- 2018-09-01
- Last updated by the study team
- 2018-06-27
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.