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NCT04231721
High Resolution Colonic Manometry in Relation to 3D-Transit Times in Healthy Controls.
trial testing High Resolution Colonic Manometry and 3D-Transit system in Healthy in 20 participants. Status unknown.
28 February 2023
Quick facts
| Lead sponsor | Janne Ladefoged Fassov |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 1 February 2020 |
| Primary completion | 28 February 2023 |
| Estimated completion | 28 February 2023 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- High Resolution Colonic Manometry and 3D-Transit system
Conditions studied
- Healthy — all drugs for Healthy →
- Colonic Motility — all drugs for Colonic Motility →
Sponsor
Janne Ladefoged Fassov
Who can join
Adults 18 to 70, any sex, with Healthy or Colonic Motility. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Within recent years, new methods for detailed assessment of gastrointestinal (GI) motility have been developed. Hence, the electromagnetic 3D-Transit system is a safe, non-invasive method for detailed description of GI motility. The system tracks the exact position of an ingested electromagnetic capsule through the entire GI tract and provides detailed information on both regional transit- and contraction patterns. High Resolution Colonic Manometry (HRCM) allows extremely detailed description of contraction patterns in the colon. The HRCM is however an invasive method, as the catheter is placed during colonoscopy. Before widespread use of capsule-based techniques (3D-Transit or others), the system needs to be validated by another method. Study Objectives: The purpose of this study is to investigate weather pressure changes measured by HRCM correlate with passage patterns recorded by 3D-Transit. This has been assumed so far, but has never been further investigated. Hypothesis: Movement of the electromagnetic 3D-Transit capsule within the colon correspond well with pressure changes determined with HRCM. Materials and methods: HRCM and 3D-transit will be performed simultaneously in 20 healthy participants. A colonoscopy is performed to install the HRCM catheter and place two 3D-Transit capsules within the colon. For 24 hours, the participants lie in a bed in the research lab while pressure changes from the HRCM catheter are recorded and the 3D-Transit capsules are followed through the gastrointestinal system. Perspectives: If data from the 3D-Transit technique correlate well with HRCM, the method provide a non-invasive alternative allowing detailed assessment of colonic motility.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04231721
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04231721 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Janne Ladefoged Fassov
- Last refreshed: 22 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04231721.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing