Post-operative IleusGTECHPOINCT02673671
G-Tech Feasibility Study for Early Detection of a Post-op Ileus
An observational study of Post-operative Ileus, run by G-Tech Corporation at 1 site in United States.
Trial summary
This feasibility study is for the purpose of determining if the G-Tech Device can differentiate between normal return of GI activity post-operatively and the myoelectric activity in patients who develop a POI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Ileus
- What is being tested?
- G-Tech Myoelectric recording device
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Dec 2023
- 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: The study population will include candidates who undergo GI surgery or other surgery outside not involving the abdominal cavity, who agree to the application of the G-Tech Device to be placed on his/her abdomen and meet all eligibility criteria as defined. Up to 100 subjects may be consented prior to surgery who are planned to undergo gastrointestinal surgery or a planned surgery that does not involve the abdominal cavity or following. Up to 50 subjects who have undergone gastrointestinal surgery or surgery not involving the abdominal cavity may be consented post-operatively during their hospital stay for this study.
Who may be able to join
- Willing and able to provide informed consent;
- Eighteen (18) years of age or older;
- Subject is willing and able to follow all study requirements;
- Subject who will undergo or has undergone open or laparoscopic gastrointestinal surgery or surgery not involving the abdominal cavity.
Who cannot join
- Subject is pregnant or suspects pregnancy;
- Known allergy to medical grade adhesive;
- Weight > 350 lbs (159 Kg);
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
El Camino Hospital
Mountain View, California, 94040
Steve Axelrod, PhD, 650-269-1479, steve.axelrod@gtechhealth.com
Anand Navalgund, PhD, 614-886-7789, anand.navalgund@gtechhealth.com
About this study
Official title: Measurement Of GI Myoelectric Activity In Patients At Risk For Or Who Have A Post-Operative Ileus (POI) - Monitoring/ Recording GI Myoelectric Activity For Early Detection of A POI
This feasibility study is for the purpose of determining if the G-Tech Device can differentiate between normal return of GI activity post-operatively and the myoelectric activity in patients who develop a POI.
Read the detailed description
While preventing the development of a POI is most important, POIs still occur; therefore, it is important to definitively diagnose a POI as early as possible during the post-operative course for treatment to prevent patient discomfort, complications, and extended hospital stay. The purpose of the G-Tech study is to determine if the G-Tech Device can detect a difference in the myoelectric signals from patients who develop a POI compared to those patients who do not develop a POI. It is anticipated that up to 20% of patients enrolled in this study and consented preoperatively, excluding screen failures, will show evidence of a post-operative ileus as detected by the G-Tech GutCheck Device and differentiate the myoelectric signals from the patients who do not develop a POI. Patients who are known to have developed a POI may also be selected for the study.
- Conditions
- Post-operative Ileus
- Being tested
- G-Tech Myoelectric recording device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-Tech Myoelectric recording deviceDevice
Also called Gastro-intestinal electrical recording
A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with unknown POI status consented pre-surgery | Up to 100 subjects may be consented prior to surgery who are planned to undergo gastrointestinal surgery or a planned surgery that does not involve the abdominal cavity. The investigator does not change the routine medical care of study participants. Receives: Device: G-Tech Myoelectric recording device | |
| Subjects with known/unknown POI status consented post-surgery | Up to 50 subjects who have undergone gastrointestinal surgery or surgery not involving the abdominal cavity may be consented post- operatively during their hospital stay for this study.The investigator does not change the routine medical care of study participants. Receives: Device: G-Tech Myoelectric recording device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myoelectric activity pattern in POI patients versus non-POI patients
The resumption of motor activity in the stomach, small intestine, and colon post-operatively. The measurement is myoelectric signals measured at the skin surface similar to ECG recordings for the heart
Measured: Up to 6 Days
Secondary outcomes (3)
Anticipated Adverse Events
Device related anticipated adverse events; such as, skin irritation due to adhesive from the skin patch.
Measured: Up to 6 days
UADEs
Unanticipated adverse device effects
Measured: Up to 6 Days
Device Success
Device success defined as the ability to record GI myoelectric activity following GI surgery.
Measured: Up to 6 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-operative IleusStudies 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
- Eminence Clinical Research, Inc.
- Responsible party
- Sponsor
- Investigators
- George Triadafilopoulos, MD, Principal investigator, El Camino GI Medical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673671
- Sponsor's protocol ID
- CLP-2014-001
- Acronym
- GTECHPOI
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2016
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Analyses planned to be presented at scientific meetings and published in peer reviewed medical journals.
Publications
Bederman SS, Betsy M, Winiarsky R, Seldes RM, Sharrock NE, Sculco TP. Postoperative ileus in the lower extremity arthroplasty patient. J Arthroplasty. 2001 Dec;16(8):1066-70. doi: 10.1054/arth.2001.27675.
PubMed 11740765Doorly MG, Senagore AJ. Pathogenesis and clinical and economic consequences of postoperative ileus. Surg Clin North Am. 2012 Apr;92(2):259-72, viii. doi: 10.1016/j.suc.2012.01.010.
PubMed 22414412Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. doi: 10.1053/cgh.2003.50012.
PubMed 15017498Frantzides CT, Cowles V, Salaymeh B, Tekin E, Condon RE. Morphine effects on human colonic myoelectric activity in the postoperative period. Am J Surg. 1992 Jan;163(1):144-8; discussion 148-9. doi: 10.1016/0002-9610(92)90267-u.
PubMed 1733363Tropskaya NS and Popova TS. (2012). Postoperative Ileus: Pathophysiology and Treatment in Current Concepts in Colonic Disorders, Dr. Godfrey Lule (Ed.), ISBN: 978-953-307-957-8, InTech, Available from: http://www.intechopen.com/books/current-concepts-in-colonic-disorders/postoperative-ileus-pathophysiologyand-treatment.
Waldhausen JH, Shaffrey ME, Skenderis BS 2nd, Jones RS, Schirmer BD. Gastrointestinal myoelectric and clinical patterns of recovery after laparotomy. Ann Surg. 1990 Jun;211(6):777-84; discussion 785. doi: 10.1097/00000658-199006000-00018.
PubMed 2357140
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement Of GI Myoelectric Activity In Patients At Risk For Or Who Have A Post-Operative Ileus (POI) - Monitoring/ Recording GI Myoelectric Activity For Early Detection of A POI
- ClinicalTrials.gov ID
- NCT02673671
- Acronym / sponsor ID
- GTECHPOI / CLP-2014-001
- Conditions
- Post-operative Ileus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- G-Tech CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Eminence Clinical Research, Inc.
- Study start
- Feb 2016
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Feb 2016 (estimated)
- 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 feasibility study is for the purpose of determining if the G-Tech Device can differentiate between normal return of GI activity post-operatively and the myoelectric activity in patients who develop a POI.
Detailed description
While preventing the development of a POI is most important, POIs still occur; therefore, it is important to definitively diagnose a POI as early as possible during the post-operative course for treatment to prevent patient discomfort, complications, and extended hospital stay. The purpose of the G-Tech study is to determine if the G-Tech Device can detect a difference in the myoelectric signals from patients who develop a POI compared to those patients who do not develop a POI. It is anticipated that up to 20% of patients enrolled in this study and consented preoperatively, excluding screen failures, will show evidence of a post-operative ileus as detected by the G-Tech GutCheck Device and differentiate the myoelectric signals from the patients who do not develop a POI. Patients who are known to have developed a POI may also be selected for the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with unknown POI status consented pre-surgery | – | Device: G-Tech Myoelectric recording deviceUp to 100 subjects may be consented prior to surgery who are planned to undergo gastrointestinal surgery or a planned surgery that does not involve the abdominal cavity. The investigator does not change the routine medical care of study participants. |
| Subjects with known/unknown POI status consented post-surgery | – | Device: G-Tech Myoelectric recording deviceUp to 50 subjects who have undergone gastrointestinal surgery or surgery not involving the abdominal cavity may be consented post- operatively during their hospital stay for this study.The investigator does not change the routine medical care of study participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include candidates who undergo GI surgery or other surgery outside not involving the abdominal cavity, who agree to the application of the G-Tech Device to be placed on his/her abdomen and meet all eligibility criteria as defined. Up to 100 subjects may be consented prior to surgery who are planned to undergo gastrointestinal surgery or a planned surgery that does not involve the abdominal cavity or following. Up to 50 subjects who have undergone gastrointestinal surgery or surgery not involving the abdominal cavity may be consented post-operatively during their hospital stay for this study.
Key inclusion criteria (4 listed)
- Willing and able to provide informed consent;
- Eighteen (18) years of age or older;
- Subject is willing and able to follow all study requirements;
- Subject who will undergo or has undergone open or laparoscopic gastrointestinal surgery or surgery not involving the abdominal cavity.
Key exclusion criteria (3 listed)
- Subject is pregnant or suspects pregnancy;
- Known allergy to medical grade adhesive;
- Weight > 350 lbs (159 Kg);
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 Myoelectric recording deviceAlso: Gastro-intestinal electrical recordingA minimum of three patches are placed on the abdomen of the patient to record myoelectric activity. | Device | Subjects with known/unknown POI status consented post-surgery, Subjects with unknown POI status consented pre-surgery |
Primary outcome
Myoelectric activity pattern in POI patients versus non-POI patients
Time frame: Up to 6 Days
The resumption of motor activity in the stomach, small intestine, and colon post-operatively. The measurement is myoelectric signals measured at the skin surface similar to ECG recordings for the heart
3 secondary outcomes
Anticipated Adverse Events
Time frame: Up to 6 days
UADEs
Time frame: Up to 6 Days
Device Success
Time frame: Up to 6 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Background: PubMed 11740765Bederman SS, Betsy M, Winiarsky R, Seldes RM, Sharrock NE, Sculco TP. Postoperative ileus in the lower extremity arthroplasty patient. J Arthroplasty. 2001 Dec;16(8):1066-70. doi: 10.1054/arth.2001.27675.
- Background: PubMed 22414412Doorly MG, Senagore AJ. Pathogenesis and clinical and economic consequences of postoperative ileus. Surg Clin North Am. 2012 Apr;92(2):259-72, viii. doi: 10.1016/j.suc.2012.01.010.
- Background: PubMed 15017498Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. doi: 10.1053/cgh.2003.50012.
- Background: PubMed 1733363Frantzides CT, Cowles V, Salaymeh B, Tekin E, Condon RE. Morphine effects on human colonic myoelectric activity in the postoperative period. Am J Surg. 1992 Jan;163(1):144-8; discussion 148-9. doi: 10.1016/0002-9610(92)90267-u.
- BackgroundTropskaya NS and Popova TS. (2012). Postoperative Ileus: Pathophysiology and Treatment in Current Concepts in Colonic Disorders, Dr. Godfrey Lule (Ed.), ISBN: 978-953-307-957-8, InTech, Available from: http://www.intechopen.com/books/current-concepts-in-colonic-disorders/postoperative-ileus-pathophysiologyand-treatment.
- Background: PubMed 2357140Waldhausen JH, Shaffrey ME, Skenderis BS 2nd, Jones RS, Schirmer BD. Gastrointestinal myoelectric and clinical patterns of recovery after laparotomy. Ann Surg. 1990 Jun;211(6):777-84; discussion 785. doi: 10.1097/00000658-199006000-00018.
- Individual participant dataSharing planned: No. Analyses planned to be presented at scientific meetings and published in peer reviewed medical journals.
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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.
George Triadafilopoulos, MD principal investigator
El Camino GI Medical Associates
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 Post-operative 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 3 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 20 Jan 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 Steve Axelrod, PhD (650-269-1479, steve.axelrod@gtechhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myoelectric activity pattern in POI patients versus non-POI patients (time frame: Up to 6 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02673671, which also lists 6 linked publications.
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 20 Jan 2023.