Clinical Luminal Endoscopic Assessment of a Novel Suction (CLEANS) Technique for the Treatment of Esophageal Food Impaction
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Biomerics, LLC
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Food Bolus Clearance
Study Overview
Brief 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.
Detailed Description
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
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Esophageal food impaction requiring endoscopic intervention.
- •Male or female.
- •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.
Outcomes
Primary Outcomes
Food Bolus Clearance
Time Frame: During procedure
The first primary endpoint will be to assess the complete food bolus clearance rate.
Time to Clearance
Time Frame: During procedure
The second will be time to complete clearance.
Secondary Outcomes
- Ease of Use(Immediately following procedure)
- Satisfaction(Immediately following procedure)