NaviCam Patency Capsule to Verify Gastrointestinal Patency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NaviCam Patency Capsule.
- Who it may be relevant to
- Registry conditions: Intestinal Stricture, Crohn Disease, NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy, Abdominal Pain. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Single Center Clinical Trial Assessing the Efficacy and Safety of the NaviCam Patency Capsule to Verify Gastrointestinal Patency
Overview
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.
Detailed description
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.
Interventions
- Device NaviCam Patency Capsule
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.
Primary outcome measures
- Safety of patency capsule [Time frame: 30 hours]
- Efficacy of patency capsule [Time frame: 30 hours]
Eligibility criteria
Inclusion criteria
- Patients with suspected or known intestinal stricture (with medical history records, physical examination records, and imaging evidence within the last 6 months.
- Patients suffering from Crohn's Disease
- Patients with long-term use of non-steroidal anti-inflammatory drugs.
- Patients with abdominal symptoms related to intestinal stricture.
- Patients with chronic inflammatory diseases.
- Patients with difficulty with balloon-assisted endoscopy (BAE).
- Patients with a history of small bowel obstruction.
- Patients with a history of intestinal resection surgery.
Exclusion criteria
- Patients with esophageal obstruction or swallowing disorder diseases.
- Patients who are ineligible for surgery or refuse to undergo any abdominal surgery.
- Patients with known allergies or other contraindications or intolerance to the medications used in this study.
- Patients with pacemakers or other implanted electronic devices such as cochlear implants, magnetic metal drug infusion pumps, neurostimulators.
- Pregnant women
- Patients currently enrolled in another drug or device clinical trial.
- Other conditions deemed unsuitable for inclusion by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Digestive Health Services — Downers Grove
Publications
- 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. PMID 31915319
- 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. PMID 24698874
- 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. PMID 29718225
- 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. PMID 17577114
- 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. PMID 18355824
- 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. PMID 27652302
Identifiers
NCT: NCT07649720 · P11_CEP-0001