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Participants included in this study will first swallow a patency capsule and then undergo an abdominal X-ray scan within 30 hours after swallowing the capsule to confirm weather the capsule is still in the body.
If the X-ray scan indicates that the capsule is not in the body or shows that the patency capsule is in the colonic area or if an intact patency capsule is found in the bowel movement, it proves that the intestine is patent, and the patient can undergo an examination using capsule endoscopy. If the X-ray scan shows that the capsule is still in the small bowel area, it indicates that there may be stricture(s) in the intestines, and then small bowel capsule endoscopy may not be performed.
The patency capsule is a disposable medical device composed of medicinal excipients in the shape of a dissolvable passive capsule and will dissolve over time if not excreted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm patency capsule evaluation | Experimental | Participants will first swallow a patency capsule and then undergo an abdominal X-ray scan within 30 hours after swallowing the capsule to confirm whether the capsule is still in the body. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaviCam Patency Capsule | Device | The NaviCam Patency Capsule is an accessory to the NaviCam capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the NaviCam capsule in patients with known or suspected strictures. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of patency capsule | The number of patients successfully passing the Patency Capsule within 30 hours compared to the number of patients where the Patency Capsule dissolves in patients with strictures. | 30 hours |
| Efficacy of patency capsule | The percentage of patients that successfully pass the Patency capsule within 30 hours. | 30 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tim Thomas, RAC | Contact | 770-480-2911 | tim.thomas@anxrobotics.com |
| Name | Affiliation | Role |
|---|---|---|
| Rockford G Yapp, MD | Digestive Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Health Services | Downers Grove | Illinois | 60515 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31915319 | Background | Takeda K, Tashimo H, Miyakawa K, Shimada M, Ohshima N, Tamura A, Nagai H, Matsui H. Patency Capsule Aspiration. Intern Med. 2020 Apr 15;59(8):1071-1073. doi: 10.2169/internalmedicine.4012-19. Epub 2020 Jan 9. | |
| 24698874 | Background | Okoli A, Ammannagari N, Mazumder M, Nakkala K. When the dissolvable does not dissolve: an agile patency capsule mystery. Am J Gastroenterol. 2014 Apr;109(4):605-7. doi: 10.1038/ajg.2013.435. No abstract available. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Participants in this study will first swallow a patency capsule and then undergo an abdominal X-ray within 30 hours after swallowing the patency capsule to confirm if the capsule is still in the body. The goal of the patency capsule is to screen for strictures that may interfere with the passage of an endoscopy capsule at a later time.
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| 29718225 | Background | Mitselos IV, Katsanos K, Tsianos EV, Eliakim R, Christodoulou D. Clinical Use of Patency Capsule: A Comprehensive Review of the Literature. Inflamm Bowel Dis. 2018 Oct 12;24(11):2339-2347. doi: 10.1093/ibd/izy152. |
| 17577114 | Background | Spada C, Shah SK, Riccioni ME, Spera G, Marchese M, Iacopini F, Familiari P, Costamagna G. Video capsule endoscopy in patients with known or suspected small bowel stricture previously tested with the dissolving patency capsule. J Clin Gastroenterol. 2007 Jul;41(6):576-82. doi: 10.1097/01.mcg.0000225633.14663.64. |
| 18355824 | Background | Herrerias JM, Leighton JA, Costamagna G, Infantolino A, Eliakim R, Fischer D, Rubin DT, Manten HD, Scapa E, Morgan DR, Bergwerk AJ, Koslowsky B, Adler SN. Agile patency system eliminates risk of capsule retention in patients with known intestinal strictures who undergo capsule endoscopy. Gastrointest Endosc. 2008 May;67(6):902-9. doi: 10.1016/j.gie.2007.10.063. Epub 2008 Mar 19. |
| 27652302 | Background | Kopylov U, Nemeth A, Cebrian A, Wurm Johansson G, Thorlacius H, Fernandez-Urien Sainz I, Koulaouzidis A, Eliakim R, Toth E. Symptomatic retention of the patency capsule: a multicenter real life case series. Endosc Int Open. 2016 Sep;4(9):E964-9. doi: 10.1055/s-0042-112588. Epub 2016 Aug 8. |
| D007410 | Intestinal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |