Gastric Motor FunctionNCT05264363
Clinical Validation of the VIPUN GMS as a Gastric Motility Monitoring System
A study testing VIPUN Gastric Monitoring System prototype in people with Gastric Motor Function, run by VIPUN Medical at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Motor Function
- What is being tested?
- VIPUN Gastric Monitoring System prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Feb 2022to 12 Dec 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Translational Research Center for Gastrointestinal Disorders - KU Leuven
Leuven, Vlaams-Brabant, 3000
About this study
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.
- Conditions
- Gastric Motor Function
- Being tested
- VIPUN Gastric Monitoring System prototype
- Keywords
- Medical device investigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIPUN Gastric Monitoring System prototypeDevice
Also called VIPUN GMS
The Investigational Medical Device (IMD) is used simultaneously with the reference device (solid state high-resolution manometry) to record gastric intraluminal pressure for approximately 2.5 hours.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The main intervention is the application of the Investigational Medical Device (VIPUN Gastric Monitoring System prototype) together with the reference device (solid state high-resolution manometry) to record intraluminal pressure. The planned procedures are identical for all subjects in this single-arm investigation. Receives: Device: VIPUN Gastric Monitoring System prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of gastric contractility on VIPUN GMS
Time the smoothed and baseline-corrected VIPUN GMS pressure exceeds the contraction-threshold.
Measured: protocol time T=0-120 minutes
Duration of gastric contractility on manometry
Time the smoothed and baseline-corrected gastric manometry pressure exceeds the contraction-threshold
Measured: protocol time T=0-120 minutes
Secondary outcomes (8)
VIPUN GMS contraction frequency
Gastric contractions identified visually by a expert gastroenterologists on the VIPUN GMS recording.
Measured: protocol time T=0-120 minutes
Manometry contraction frequency
Gastric contractions identified visually by a expert gastroenterologists on the manometry recording.
Measured: protocol time T=0-120 minutes
Motility Tiled Runner contraction frequency
Motility Tile Runner contractions are gastric contractions identified by the VIPUN Motility Tiled Runner software application.
Measured: protocol time T=0-120 minutes
Hallmarks of normal motility
The presence/absence of hallmarks of normal gastric motility are scored by expert gastroenterologists on the VIPUN GMS pressure recording and on the manometry recording independently.
Measured: protocol time T=0-150 minutes
Duration of MMC phases
The duration of MMC phase III is delineated by expert gastroenterologists on the VIPUN GMS pressure recording and on the manometry recording independently.
Measured: protocol time T=0-150 minutes
Nutrient-induced changes in tonic contractility
Defined as the difference between baseline GMS pressure before and during nutrient administration.
Measured: protocol time T=0-150 minutes
Nutrient-induced changes in phasic contractility
Defined as the difference between the frequency of Motility Tiled Runner contractions before and during nutrient administration.
Measured: protocol time T=0-150 minutes
Volume-pressure relation during stepwise inflation
The pressure at each volume increment (range 0-135 ml) is recorded during stepwise inflation of the VIPUN GMS Catheter in the esophagus and in the stomach.
Measured: Prior to protocol time T=0 minutes (=start motility recording).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start10 Feb 2022
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Motor FunctionStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, interventional, single-arm, monocentric, investigation in a cohort of adult healthy subjects comprising a screening visit and a single study visit.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIPUN Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Tack, PhD, MD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264363
- Sponsor's protocol ID
- LOTUS
- Status last verified
- Dec 2022
- First submitted
- 10 Feb 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the VIPUN GMS as a Gastric Motility Monitoring System
- ClinicalTrials.gov ID
- NCT05264363
- Acronym / sponsor ID
- LOTUS
- Conditions
- Gastric Motor Function
- Keywords
- Medical device investigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- VIPUN MedicalIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 3 Mar 2022 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, interventional, single-arm, monocentric, investigation in a cohort of adult healthy subjects comprising a screening visit and a single study visit.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: VIPUN Gastric Monitoring System prototypeThe main intervention is the application of the Investigational Medical Device (VIPUN Gastric Monitoring System prototype) together with the reference device (solid state high-resolution manometry) to record intraluminal pressure. The planned procedures are identical for all subjects in this single-arm investigation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (28 listed)
- 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
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 |
|---|---|---|
| VIPUN Gastric Monitoring System prototypeAlso: VIPUN GMSThe Investigational Medical Device (IMD) is used simultaneously with the reference device (solid state high-resolution manometry) to record gastric intraluminal pressure for approximately 2.5 hours. | Device | Intervention |
Primary outcome
Duration of gastric contractility on VIPUN GMS
Time frame: protocol time T=0-120 minutes
Time the smoothed and baseline-corrected VIPUN GMS pressure exceeds the contraction-threshold.
Duration of gastric contractility on manometry
Time frame: protocol time T=0-120 minutes
Time the smoothed and baseline-corrected gastric manometry pressure exceeds the contraction-threshold
8 secondary outcomes
VIPUN GMS contraction frequency
Time frame: protocol time T=0-120 minutes
Manometry contraction frequency
Time frame: protocol time T=0-120 minutes
Motility Tiled Runner contraction frequency
Time frame: protocol time T=0-120 minutes
Hallmarks of normal motility
Time frame: protocol time T=0-150 minutes
Duration of MMC phases
Time frame: protocol time T=0-150 minutes
Nutrient-induced changes in tonic contractility
Time frame: protocol time T=0-150 minutes
Nutrient-induced changes in phasic contractility
Time frame: protocol time T=0-150 minutes
Volume-pressure relation during stepwise inflation
Time frame: Prior to protocol time T=0 minutes (=start motility recording).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Jan Tack, PhD, MD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIPUN Gastric Monitoring System prototype in people with Gastric Motor Function, run by VIPUN Medical at 1 site in Belgium.
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 5 inclusion and 28 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: finished, as of the sponsor's last update on 21 Dec 2022. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of gastric contractility on VIPUN GMS (time frame: protocol time T=0-120 minutes). 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 21 Dec 2022.