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NCT04307901: SOCRATEC
Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy
trial testing Colon capsule endoscopy in Colorectal Cancer in 600 participants. Currently enrolling.
1 October 2030
Quick facts
| Lead sponsor | Odense University Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 600 |
| Start date | 1 May 2020 |
| Primary completion | 1 October 2030 |
| Estimated completion | 31 December 2030 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Colon capsule endoscopy
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Colorectal Polyp — all drugs for Colorectal Polyp →
Sponsor
Odense University Hospital
Who can join
18 and older, any sex, with Colorectal Cancer or Colorectal Polyp. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Following European guidelines patients undergoing colonoscopy in one of Odense University Hospitals units will now be offered a colon capsule endoscopy (CCE) in case of incomplete examinations. Patients formerly referred to colonoscopy in general anesthesia or patients who decline colonoscopy after having completed bowel preparation will also be offered a CCE. In our department we have conducted a comparison study documenting that the sensitivity of CCE is superior to CT colonography in both polyps \>9 mm and polyps \>5 mm, which is also supported by an Italian study. The safety and completion rate of CCE following incomplete colonoscopy is confirmed by several studies including one multicenter study and the completion rate is not significantly lower compared to other patient groups. In an incomplete colonoscopy it is always the most oral part of the colon which is not visualized, whereas in CCE, an incomplete investigation will most often have visualized the oral part. By combining incomplete colonoscopy results and incomplete CCE results we can identify patients who have had a complete colon investigation although both investigations were incomplete. Aim: to investigate the quality of CCE and the completion rate in patients who have undergone an incomplete colonoscopy, have completed bowel preparation but declines colonoscopy or have been referred to colonoscopy in general anesthesia.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Colon capsule endoscopy following incomplete colonoscopy in routine clinical settings.
Havshoi AV, Deding U, Jensen SS, Andersen PV, et al · · 2023 · cited 2× · PMID 36471059 · DOI 10.1007/s00464-022-09783-w
Verify or expand the search:
- PubMed search for NCT04307901
- 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 NCT04307901 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Odense University Hospital
- Last refreshed: 20 May 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/NCT04307901.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing