NaviCam Patency Capsule to Verify Gastrointestinal Patency

NCT07649720 | Not Yet Recruiting FDA Device

• 1 other identifier: P11_CEP-0001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intestinal Stricture; Crohn Disease; NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy; Abdominal Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Device: NaviCam Patency Capsule

Interventions

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.

Single arm patency capsule evaluation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AnX Robotica Corp.: lead

Study Sites (1)

Digestive Health Services

Downers Grove, Illinois, 60515, United States

Location

Related Publications (6)

• 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 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.

  PMID: 24698874 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.

  PMID: 29718225 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.

  PMID: 17577114 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.

  PMID: 18355824 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.

  PMID: 27652302 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Abdominal Pain

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Rockford G Yapp, MD

  Digestive Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tim Thomas, RAC

CONTACT

770-480-2911; tim.thomas@anxrobotics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 16, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

US (1)