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NCT03881436: TractoCA
Assessment of MRI Tractography for Pelvic Floor Sphincter Analysis
NA trial testing MRI with DTI sequence in Inflammatory Bowel Disease in 23 participants. Completed in 12 August 2021.
12 August 2021
Quick facts
| Lead sponsor | IHU Strasbourg |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 23 |
| Start date | 12 August 2019 |
| Primary completion | 12 August 2021 |
| Estimated completion | 12 August 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- MRI with DTI sequence
Conditions studied
- Inflammatory Bowel Disease — all drugs for Inflammatory Bowel Disease →
- Neoplastic Pathology — all drugs for Neoplastic Pathology →
Sponsor
IHU Strasbourg — full company profile →
Who can join
18 and older, any sex, with Inflammatory Bowel Disease or Neoplastic Pathology. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Urinary and faecal incontinences generally come from a dysfunction of the pelvic floor muscles, and more particularly the sphincters. Among other causes, they may be related to accidental trauma, obstetric or iatrogenic. On this last point, the incidence of surgical interventions on the bladder collar and on the anal canal on the prevalence of incontinences can be underlined. MRI tractography could be an interesting tool to visualize in 3D the structure of pelvic sphincters and their lesions. It may thereby establish the link with observed dysfunctions, thus potentially providing a complement to the urological and proctographic examinations already carried out. The objective of this study is, first, to define the sensitivity of the MRI tractography for the visualization of the pelvic sphincters architecture regardless of the gender. In a second time, it will give a description of normal and abnormal (pathological cases) tractography, as well as a descriptive post-surgery. The other interest of this study is the assessment of the information provided by pelvic sphincters tractography on a panel of various and frequently encountered situations in clinical routine at the IHU.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Evaluation of the anal canal using diffusion tensor imaging (DTI) with fiber tractography: prospective study of treated perianal fistula
Knaub E, Giraudeau C, Molière S, Venkatasamy A, et al · · 2022 · DOI 10.21203/rs.3.rs-1519407/v1
Verify or expand the search:
- PubMed search for NCT03881436
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03881436 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IHU Strasbourg
- Last refreshed: 29 March 2022
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/NCT03881436.
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