GTECHPOI: G-Tech Feasibility Study for Early Detection of a Post-op Ileus
Study Details
Study Description
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 | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | 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 Names:
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| 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 Names:
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Outcome Measures
Primary Outcome Measures
- Myoelectric activity pattern in POI patients versus non-POI patients [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
- Anticipated Adverse Events [Up to 6 days]
Device related anticipated adverse events; such as, skin irritation due to adhesive from the skin patch.
- UADEs [Up to 6 Days]
Unanticipated adverse device effects
- Device Success [Up to 6 Days]
Device success defined as the ability to record GI myoelectric activity following GI surgery.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Willing and able to provide informed consent;
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Eighteen (18) years of age or older;
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Subject is willing and able to follow all study requirements;
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Subject who will undergo or has undergone open or laparoscopic gastrointestinal surgery or surgery not involving the abdominal cavity.
Exclusion Criteria:
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Subject is pregnant or suspects pregnancy;
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Known allergy to medical grade adhesive;
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Weight > 350 lbs (159 Kg);
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | El Camino Hospital | Mountain View | California | United States | 94040 |
Sponsors and Collaborators
- G-Tech Corporation
- Eminence Clinical Research, Inc.
Investigators
- Principal Investigator: George Triadafilopoulos, MD, El Camino GI Medical Associates
Study Documents (Full-Text)
None provided.More Information
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.
- Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. Review.
- Doorly 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. Review.
- Frantzides 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.
- Tropskaya 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.
- CLP-2014-001