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Not yet recruitingNCT07649720PATENCYUpdated Jun 16, 2026

NaviCam Patency Capsule to Verify Gastrointestinal Patency

An interventional study of NaviCam Patency Capsule in Intestinal Stricture, Crohn Disease and NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy, sponsored by AnX Robotica Corp.. Not yet recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by AnX Robotica Corp. · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 25 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

AnX Robotica Corp. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Single arm patency capsule evaluation

    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

  • DeviceNaviCam 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 hours

  2. Efficacy of patency capsule

    The percentage of patients that successfully pass the Patency capsule within 30 hours.

    Time frame: 30 hours

07

Study locations

1 site
  • Digestive Health Services
    Downers Grove, Illinois 60515, United States
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 27652302 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07649720
Lead sponsor
AnX Robotica Corp.
Responsible party
Sponsor
First posted
Jun 16, 2026
Start date
Jun 15, 2026 (estimated)
Primary completion
Dec 15, 2026 (estimated)
Completion
Mar 15, 2027 (estimated)
Last update
Jun 16, 2026

Study contacts

Tim Thomas, RAC
Contact
tim.thomas@anxrobotics.com
770-480-2911
Rockford G Yapp, MD
principal investigator · Digestive Health Services

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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