Recruiting

G-Tech Device

Sponsor:

G-Tech Corporation

Code:

NCT02673671

Conditions

Post-operative Ileus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

G-Tech Myoelectric recording device

Study Details

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.

Conditions

Post-operative Ileus

Study ID

NCT02673671

Start date

Feb, 2016

Status verified date

Jan, 2023

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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);

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

G-Tech Myoelectric recording device

A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity.

Primary outcome measure

  • Myoelectric activity pattern in POI patients versus non-POI patients [ Time Frame: Up to 6 Days ]

Central Contacts and Locations

Central contacts

Steve Axelrod, PhD

650-269-1479steve.axelrod@gtechhealth.com

Locations

El Camino Hospital

Recruiting

Mountain View, California, United States, 94040

Contacts

Steve Axelrod, PhD

650-269-1479steve.axelrod@gtechhealth.com

Anand Navalgund, PhD

614-886-7789anand.navalgund@gtechhealth.com

More Information

Sponsor

G-Tech Corporation

Last update posted

Jan 20, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by G-Tech Corporation on 2023-01-20.