Clinical Validation of the VIPUN GMS as a Gastric Motility Monitoring System

  • STATUS
    Recruiting
  • days left to enroll
    54
  • participants needed
    13
  • sponsor
    VIPUN Medical
Updated on 11 August 2022
Accepts healthy volunteers

Summary

In order to validate that the VIPUN, Gastric Monitoring System (GMS) is a gastric motility monitoring system, we intend to show that the VIPUN GMS can assess motility through pressure measurement similar to high-resolution manometry (HRM).

In addition, the study aims to contribute to the design and development of a position confirmation functionality integrated in the VIPUN Gastric Monitoring System by establishing volume-pressure relations in the stomach and esophagus.

Details
Condition Gastric Motor Function
Treatment VIPUN Gastric Monitoring System prototype
Clinical Study IdentifierNCT05264363
SponsorVIPUN Medical
Last Modified on11 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed Informed Consent Form
Aged between and including 18 and 65 years
In good health on the basis of medical history and anamnesis by the Principal Investigator (or delegate)
Agrees to refrain from drug, non-allowed medication, herbal supplement and dietary supplement intake on the day of the study visit
Agrees to an overnight fast in advance of the study visit

Exclusion Criteria

Current or chronic gastrointestinal symptoms
Use of any medication that might affect gastric function or visceral sensitivity in the opinion of the PI
(Suspected) current use of illicit drugs
Psychiatric or neurological illness
Any history of gastrointestinal surgery that could influence normal gastric function in the opinion of the PI, including, but not limited to gastrectomy, esophagectomy, duodenotomy, pancreatectomy, bariatric surgery (bypass surgery, gastric banding…), placement of neuromodulator
Simultaneous participation in other clinical studies
Suspected or confirmed basal skull fracture, mid face trauma or maxillofacial trauma
Nasopharyngeal surgery in the last 30 days
History of severe coagulation abnormalities
Therapeutic or prophylactic anticoagulation
Gastrointestinal bleeding
Ischemic bowel
Peritonitis
Deviated nasal septum impeding catheter placement
Inability to pass a feeding tube through the nares (e.g. in case of anatomical features, nasal congestion or blockage)
Recent (< 30 days) caustic ingestion (due to risk of esophageal rupture)
Recent (< 30 days) esophageal varices (active, untreated or recently banded/cauterized)
History of esophageal strictures
History of gastric varices
History of gastric obstruction
History of gastrectomy, esophagectomy, duodeno-pancreatectomy, bypass surgery, gastric banding, bariatric balloon, or short bowel syndrome
History of gastrostomy
Allergy to components of the VIPUN Catheter
Pregnancy or breastfeeding
Allergy to components of the enteral nutrition
Allergy to the available lubricants
Allergy to the available local anesthetic
Recent infection with SARS-CoV-2 (in the last 2 weeks prior to study visit)
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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