Esophageal Food ImpactionNCT03570567
CLEANS Technique for the Treatment of Esophageal Food Impaction
A study testing Piranha Treatment in people with Esophageal Food Impaction, run by Biomerics, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Food Impaction
- What is being tested?
- Piranha Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2018to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Robert Ganz, MD, 612-871-1145, gastrodude@visi.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Food Impaction
- Being tested
- Piranha Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piranha TreatmentDevice
The piranha device is used with an endoscope to breakup/dislodge the food bolus.
| Study group | Role | What they receive |
|---|---|---|
| Piranha Treatment | Other | The food impaction will be treated using the Piranha endoscopic device. Receives: Device: Piranha Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Bolus Clearance
The first primary endpoint will be to assess the complete food bolus clearance rate.
Measured: During procedure
Time to Clearance
The second will be time to complete clearance.
Measured: During procedure
Secondary outcomes (2)
Ease of Use
Ease of use of the technique as assessed on a 5-point visually continuous scale.
Measured: Immediately following procedure
Satisfaction
Overall satisfaction with the technique assessed on a 5-point visually continuous scale.
Measured: Immediately following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study startJun 2018 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Food ImpactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomerics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570567
- Sponsor's protocol ID
- M015-3-01
- Status last verified
- Jun 2018
- First submitted
- 18 Jun 2018
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Luminal Endoscopic Assessment of a Novel Suction (CLEANS) Technique for the Treatment of Esophageal Food Impaction
- ClinicalTrials.gov ID
- NCT03570567
- Acronym / sponsor ID
- M015-3-01
- Conditions
- Esophageal Food Impaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Biomerics, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2018 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Piranha Treatment | Other | Device: Piranha TreatmentThe food impaction will be treated using the Piranha endoscopic device. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piranha TreatmentThe piranha device is used with an endoscope to breakup/dislodge the food bolus. | Device | Piranha Treatment |
Primary outcome
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.
2 secondary outcomes
Ease of Use
Time frame: Immediately following procedure
Satisfaction
Time frame: Immediately following procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Esophageal Food Impaction
Active, not recruiting
Cola Ingestion for Esophageal Bolus Impaction
Esophageal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piranha Treatment in people with Esophageal Food Impaction, run by Biomerics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Ganz, MD (612-871-1145, gastrodude@visi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Bolus Clearance (time frame: During procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.