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G-Tech Feasibility Study for Early Detection of a Post-op Ileus (GTECHPOI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673671
Recruitment Status : Recruiting
First Posted : February 4, 2016
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Eminence Clinical Research, Inc.
Information provided by (Responsible Party):
G-Tech Corporation

Brief 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.

Condition or disease Intervention/treatment
Post-operative Ileus Device: G-Tech Myoelectric recording device

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : February 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Group/Cohort Intervention/treatment
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.
Device: G-Tech Myoelectric recording device
A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity.
Other Name: Gastro-intestinal electrical recording

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.
Device: G-Tech Myoelectric recording device
A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity.
Other Name: Gastro-intestinal electrical recording




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Anticipated Adverse Events [ Time Frame: Up to 6 days ]
    Device related anticipated adverse events; such as, skin irritation due to adhesive from the skin patch.

  2. UADEs [ Time Frame: Up to 6 Days ]
    Unanticipated adverse device effects

  3. Device Success [ Time Frame: Up to 6 Days ]
    Device success defined as the ability to record GI myoelectric activity following GI surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Willing and able to provide informed consent;
  2. Eighteen (18) years of age or older;
  3. Subject is willing and able to follow all study requirements;
  4. Subject who will undergo or has undergone open or laparoscopic gastrointestinal surgery or surgery not involving the abdominal cavity.

Exclusion Criteria:

  1. Subject is pregnant or suspects pregnancy;
  2. Known allergy to medical grade adhesive;
  3. Weight > 350 lbs (159 Kg);
  4. Has undergone a prior vagotomy;
  5. Subject has an implanted medical devices such as a pacemaker, medication pump, neurostimulator, or gastric stimulator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673671


Contacts
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Contact: Steve Axelrod, PhD 650-269-1479 steve.axelrod@gtechhealth.com

Locations
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United States, California
El Camino Hospital Recruiting
Mountain View, California, United States, 94040
Contact: Steve Axelrod, PhD    650-269-1479    steve.axelrod@gtechhealth.com   
Contact: Anand Navalgund, PhD    614-886-7789    anand.navalgund@gtechhealth.com   
Sponsors and Collaborators
G-Tech Corporation
Eminence Clinical Research, Inc.
Investigators
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Principal Investigator: George Triadafilopoulos, MD El Camino GI Medical Associates
Publications:
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Responsible Party: G-Tech Corporation
ClinicalTrials.gov Identifier: NCT02673671    
Other Study ID Numbers: CLP-2014-001
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Analyses planned to be presented at scientific meetings and published in peer reviewed medical journals.
Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases