Gastrointestinal DiseasesGRIPSNCT05712525
Gut Recovery In Patients Following Surgery
An observational study of Gastrointestinal Diseases and Ileus, run by G-Tech Corporation at 1 site in United States.
Trial summary
The purpose of the study is to determine if the myoelectrical measurements made by the G-Tech Wireless Patch System correlate with clinical markers of postoperative recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Diseases, Ileus
- What is being tested?
- G-Tech Wireless Patch System (WPS)
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2022to 6 Oct 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo a colectomy
Who may be able to join
- Willing and able to follow all study requirements
- Eighteen (18) years of age or older
- Subject is willing and able to follow all study requirements
- Subject will undergo a colectomy
Who cannot join
- Subject is pregnant or suspects pregnancy
- Known allergy to medical grade adhesive
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Anna George, MS, 617-632-7031, ageorge5@bidmc.harvard.edu
About this study
The purpose of the study is to determine if the myoelectrical measurements made by the G-Tech Wireless Patch System correlate with clinical markers of postoperative recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness. Subsequently the data will be studied to establish which information in the signals is important in determining when to feed patients and possibly discharge them..
Read the detailed description
Measure myoelectric signals with the G-Tech WPS and determine if a correlation exists between signal strength and the rate of gastrointestinal recovery following surgery. Determine the relationship between gastrointestinal myoelectrical signal strength and clinical markers of recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness.
- Conditions
- Gastrointestinal Diseases, Ileus
- Being tested
- G-Tech Wireless Patch System (WPS)
- Medical subject headings
- Gastrointestinal Diseases, Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-Tech Wireless Patch System (WPS)Diagnostic test
Noninvasive monitoring of myoelectrical signals
What is being measured
The primary outcome is the main question the study is designed to answer.
GI Functional Recovery
Observe a correlation between signal strength and the rate of gastrointestinal recovery following surgery.
Measured: 30 days after surgery
Secondary outcomes (1)
Adverse Events
Anticipated adverse events through hospitalization; Unanticipated adverse events (UADEs) through hospitalization
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start7 Oct 2022
- Primary completion6 Oct 2023 (estimated)
- Study completion6 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G-Tech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beth Israel Deaconess Medical Center
- Responsible party
- Sponsor
- Investigators
- Kristen Crowell, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712525
- Sponsor's protocol ID
- CLP-2022-001
- Acronym
- GRIPS
- Status last verified
- Jan 2023
- First submitted
- 25 Jan 2023
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Recovery In Patients Following Surgery
- ClinicalTrials.gov ID
- NCT05712525
- Acronym / sponsor ID
- GRIPS / CLP-2022-001
- Conditions
- Gastrointestinal Diseases, Ileus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- G-Tech CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 6 Oct 2023 (estimated)
- Study completion
- 6 Oct 2024 (estimated)
- First posted
- 3 Feb 2023 (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.
The purpose of the study is to determine if the myoelectrical measurements made by the G-Tech Wireless Patch System correlate with clinical markers of postoperative recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness. Subsequently the data will be studied to establish which information in the signals is important in determining when to feed patients and possibly discharge them..
Detailed description
Measure myoelectric signals with the G-Tech WPS and determine if a correlation exists between signal strength and the rate of gastrointestinal recovery following surgery. Determine the relationship between gastrointestinal myoelectrical signal strength and clinical markers of recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo a colectomy
Key inclusion criteria (4 listed)
- Willing and able to follow all study requirements
- Eighteen (18) years of age or older
- Subject is willing and able to follow all study requirements
- Subject will undergo a colectomy
Key exclusion criteria (2 listed)
- Subject is pregnant or suspects pregnancy
- Known allergy to medical grade adhesive
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 |
|---|---|---|
| G-Tech Wireless Patch System (WPS)Noninvasive monitoring of myoelectrical signals | Diagnostic test | – |
Primary outcome
GI Functional Recovery
Time frame: 30 days after surgery
Observe a correlation between signal strength and the rate of gastrointestinal recovery following surgery.
1 secondary outcome
Adverse Events
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
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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.
Kristen Crowell, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Diseases and Ileus, run by G-Tech Corporation 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 2 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 3 Feb 2023. 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 C Kirby, BS, MBA (9497517704, rob@gtechmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI Functional Recovery (time frame: 30 days after surgery). 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 3 Feb 2023.