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| Name | Class |
|---|---|
| Medtronic Spine LLC | INDUSTRY |
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This study is to examine the benefits of newly designed capsule with enhanced frame rate and wide angle compared to standard endoscopy, which may help enhance detecting esophageal diseases that otherwise may have been out of vision in the standard endoscopy, ultimately decreasing healthcare costs.
This is a pilot, single center, prospective, tandem study. All veteran patients with Barrett's esophagus scheduled for an upper EGD at Veterans Affairs Medical Center (Kansas City, MO, USA) for check-up of BE will be asked to swallow the pillcam prior to an EGD. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study
Eligible subjects at the participating institution who meet the inclusion criteria for this study will be offered the opportunity to participate in this clinical trial. To ensure that subjects are approached for potential study participation without bias, a Subject Screening Log will be maintained. This Log will track the basic demographic information of each subject approached for clinical trial inclusion and the resulting reason for exclusion from the clinical study if applicable.
The duration of the study is expected to be approximately 12 months. Enrollment of Study patients will cease when approximately 20 patients have been enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pill cam and EGD | Patients in this arm is requested to swallow the esophageal capsule and then undergo standard EGD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pill cam | Device | Patient is asked to swallow the esophageal capsule. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The overall diagnostic accuracy of capsule endoscopy in predicting the presence and extent of Barrett's esophagus in comparison to standard esophagogastroduodenoscopy | The ability to accurately predict the presence of Barrett's esophagus by capsule endoscopy and standard EGD will be measured. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment related adverse events of capsule endoscopy in comparison to standard esophagogastroduodenoscopy | Wireless capsule endoscopy is generally considered safe. Potential risks resulting from capsule endoscopy are reported low and may include discomfort while swallowing, accidental aspiration and capsule retention leading to small bowel obstruction and perforation. the investigator will measure tolerability of capsule endoscopy as well as standard endoscopy using visual analogue scale. |
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Inclusion Criteria:
Exclusion Criteria:
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This is a pilot, single center, prospective, tandem study. All veteran patients with Barrett's esophagus scheduled for an upper EGD at Veterans Affairs Medical Center (Kansas City, MO, USA) for check-up of BE will be asked to swallow the pillcam prior to an EGD.
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| Name | Affiliation | Role |
|---|---|---|
| Prateek Sharma, MD | Kansas City VA Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansas City VA Medical Center | Kansas City | Missouri | 64128 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20032324 | Background | Sharma P. Clinical practice. Barrett's esophagus. N Engl J Med. 2009 Dec 24;361(26):2548-56. doi: 10.1056/NEJMcp0902173. No abstract available. | |
| 16000923 | Background | Eliakim R, Sharma VK, Yassin K, Adler SN, Jacob H, Cave DR, Sachdev R, Mitty RD, Hartmann D, Schilling D, Riemann JF, Bar-Meir S, Bardan E, Fennerty B, Eisen G, Faigel D, Lewis BS, Fleischer DE. A prospective study of the diagnostic accuracy of PillCam ESO esophageal capsule endoscopy versus conventional upper endoscopy in patients with chronic gastroesophageal reflux diseases. J Clin Gastroenterol. 2005 Aug;39(7):572-8. doi: 10.1097/01.mcg.0000170764.29202.24. |
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This is a funded study. A copy of de-identified data set will be provided to the sponsor in the form of case report forms (CRF) at the end of the study.
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| EGD |
| Other |
Patient will undergo standard EGD |
|
| 1 year |
| 22134936 | Background | Chang JY, Talley NJ, Locke GR 3rd, Katzka DA, Schleck CD, Zinsmeister AR, Dunagan KT, Wu TT, Wang KK, Prasad GA. Population screening for barrett esophagus: a prospective randomized pilot study. Mayo Clin Proc. 2011 Dec;86(12):1174-80. doi: 10.4065/mcp.2011.0396. |
| D004066 |
| Digestive System Diseases |