G-Tech Feasibility Study for Early Detection of a Post-op Ileus
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2019 |
| Start Date: | February 2016 |
| End Date: | December 2019 |
| Contact: | Steve Axelrod, PhD |
| Email: | steve.axelrod@gtechhealth.com |
| Phone: | 650-269-1479 |
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
A feasibility study for assessing and recording myoelectric activity in patients for early
detection of a post-operative ileus (POI) in patients who undergo gastrointestinal surgery
and differentiating the myoelectric signals from those who have normal post-operative return
of GI function.
detection of a post-operative ileus (POI) in patients who undergo gastrointestinal surgery
and differentiating the myoelectric signals from those who have normal post-operative return
of GI function.
Group 1: 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
post-operative course will be assessed for both clinical symptoms and for myoelectric
activity for return to normal GI function or the development of a POI in both populations.
Group 2: 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.
gastrointestinal surgery or a planned surgery that does not involve the abdominal cavity. The
post-operative course will be assessed for both clinical symptoms and for myoelectric
activity for return to normal GI function or the development of a POI in both populations.
Group 2: 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.
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.
5. Recovery does not require prolonged gastric decompression: A nasogastric (NG) tube is
removed on or before post-op day three
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 is admitted post-operatively to a critical care or telemetry unit;
6. Subject has an implanted medical devices such as a pacemaker, medication pump,
neurostimulator, or gastric stimulator.
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El Camino Hospital El Camino Hospital is a nonprofit organization with hospital campuses in Mountain...
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