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NCT03553199: TRS
Study on a New Endoscopic Platform for the ESD of Colorectal Lesions: Tissue Retraction System
NA trial testing TRS, Tissue Retraction System in Tissue Retraction System in 15 participants. Completed in 31 December 2020.
31 December 2020
Quick facts
| Lead sponsor | Istituto Clinico Humanitas |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 28 May 2018 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- TRS, Tissue Retraction System
Conditions studied
- Tissue Retraction System — all drugs for Tissue Retraction System →
Sponsor
Istituto Clinico Humanitas
Who can join
18 and older, any sex, with Tissue Retraction System. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Endoscopic submucosal dissection (ESD) is an endoscopic technique that allows the removal of lesions of the gastrointestinal tract. The European Society of Gastrointestinal Endoscopy (ESGE) suggests to consider ESD for the removal of colorectal lesions that cannot be removed enbloc with standard polypectomy or endoscopic mucosal resection (EMR) and for lesions that are \> 20 mm in diameter, with a high probability of having a limited submucosal invasion. ESD is a technically difficult and time-consuming procedure that is very difficult to learn and to perform, but it allows higher enbloc resection rates compared to other endoscopic techniques and is less invasive than surgery requiring less length of hospital stay. Recently, several new techniques and devices have been developed to facilitate ESD and to overcome difficulties related to challenging situations. The main difficulties are related to the instability of the operating field, due to the physiologic peristalsis, and to the loss of traction, due to the single operating channel.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03553199
- 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 NCT03553199 (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 Istituto Clinico Humanitas
- Last refreshed: 18 March 2021
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/NCT03553199.
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