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| Name | Class |
|---|---|
| Eminence Clinical Research, Inc. | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-Tech Myoelectric recording device | Device | A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 6 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Anticipated Adverse Events | Device related anticipated adverse events; such as, skin irritation due to adhesive from the skin patch. | Up to 6 days |
| UADEs | Unanticipated adverse device effects |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steve Axelrod, PhD | Contact | 650-269-1479 | steve.axelrod@gtechhealth.com |
| Name | Affiliation | Role |
|---|---|---|
| George Triadafilopoulos, MD | El Camino GI Medical Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Camino Hospital | Recruiting | Mountain View | California | 94040 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11740765 | Background | 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. | |
| 22414412 | Background | 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. |
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Analyses planned to be presented at scientific meetings and published in peer reviewed medical journals.
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| Up to 6 Days |
| Device Success | Device success defined as the ability to record GI myoelectric activity following GI surgery. | Up to 6 Days |
| 15017498 | Background | Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. doi: 10.1053/cgh.2003.50012. |
| 1733363 | Background | 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. doi: 10.1016/0002-9610(92)90267-u. |
| Background | 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. |
| 2357140 | Background | 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. |