- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03570567
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Robert Ganz, MD
- Phone Number: 612-871-1145
- Email: gastrodude@visi.com
Study Contact Backup
- Name: Isaac Raijman, MD
- Phone Number: 713-795-4444
- Email: raijman.i@gmail.com
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- Abbott Northwestern Hospital
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Contact:
- Robert Ganz, MD
- Phone Number: 612-871-1145
- Email: gastrodude@visi.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Piranha Treatment
The food impaction will be treated using the Piranha endoscopic device.
|
The piranha device is used with an endoscope to breakup/dislodge the food bolus.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food Bolus Clearance
Time Frame: During procedure
|
The first primary endpoint will be to assess the complete food bolus clearance rate.
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During procedure
|
Time to Clearance
Time Frame: During procedure
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The second will be time to complete clearance.
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During procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ease of Use
Time Frame: Immediately following procedure
|
Ease of use of the technique as assessed on a 5-point visually continuous scale.
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Immediately following procedure
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Satisfaction
Time Frame: Immediately following procedure
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Overall satisfaction with the technique assessed on a 5-point visually continuous scale.
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Immediately following procedure
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- M015-3-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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