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van CCT (UK)


Effectiveness of full-thickness resection of subepithelial tumors using the Pro-select Padlock clip


- candidate number21691
- NTR NumberNTR5023
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-feb-2015
- Secondary IDs15-084  Ethics committee Utrecht
- Public TitleEffectiveness of full-thickness resection of subepithelial tumors using the Pro-select Padlock clip
- Scientific TitleEffectiveness of full-thickness resection of subepithelial tumors using the Pro-select Padlock clip
- ACRONYM
- hypothesisWe hypothesize that the commercially available CE-marked over the scope Pro-select Padlock clip is able to clip a gastic/duodenal SET, where after full thickness resection of the SET can be achieved using a normal
- Healt Condition(s) or Problem(s) studiedSubepithelial tumors of stomach or duodenum
- Inclusion criteriaAll patients undergoing full thickness resection of a subepithelial tumor in stomach or duodenum with a Padlock clip on the endoscopy department of the University medical center of Utrecht.
- Exclusion criteriaNone
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2015
- planned closingdate1-okt-2015
- Target number of participants20
- InterventionsFull thickness resection with a padlock clip
- Primary outcomeProportion of cases where radical resection of the SET is achieved
- Secondary outcome-Proportion of cases where full thickness resection is achieved
-Number of severe adverse events
-Technical difficulties with Padlock clip
- TimepointsBaseline:
patient/SET characteristics
Endoscopy; procedure data
1 week telephone call: (severe) adverse events
1 month telephone call: (severe) adverse events
3 months endoscopy: procedure data
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD W.F.W. Kappelle
- CONTACT for SCIENTIFIC QUERIESMD W.F.W. Kappelle
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD17-feb-2015 - 12-apr-2015


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