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Effectiveness of full-thickness resection in the colon using the Pro-select Padlock clip


- candidate number23603
- NTR NumberNTR5562
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jan-2016
- Secondary IDs15-419 
- Public TitleEffectiveness of full-thickness resection in the colon using the Pro-select Padlock clip
- Scientific TitleEffectiveness of full-thickness resection in the colon using the Pro-select Padlock clip
- ACRONYMPadlock-colon
- hypothesisThe aim of this study is to prospectively test the safety and feasibility of endoscopic full-thickness resection in the colon using the Pro-select Padlock clip.
- Healt Condition(s) or Problem(s) studiedFibroadenoma
- Inclusion criteria ≥18 years old
informed consent
Indication for full-thickness resection: recurrent fibrosed adenoma, adenoma located in diverticula, SET of the colon, Rx/R1 endoscopic resection of a T1 CRC
- Exclusion criteria Target lesions > 20 mm
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2015
- planned closingdate1-sep-2017
- Target number of participants20
- InterventionsEndoscopic full-thickness resection with the ProSelect PadLock clip in the colon.
- Primary outcome R0-resection rate [Timepoint: 2 weeks]
Full-thickness resection rate [Timepoint: 2 weeks]
Complication rate [Timepoint: 30 days]
- Secondary outcome Recurrence at 6 months follow-up [Timepoint: 6 months]
Patients experience 7 days after resection [Timepoint: 7 days]
Patients experience 30 days after resection [Timepoint: 30 days]
- Timepoints R0-resection rate [Timepoint: 2 weeks]v Full-thickness resection rate [Timepoint: 2 weeks]
Complication rate [Timepoint: 30 days]
Recurrence at 6 months follow-up [Timepoint: 6 months]
Patients experience 7 days after resection [Timepoint: 7 days]
Patients experience 30 days after resection [Timepoint: 30 days]
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Yara Backes
- CONTACT for SCIENTIFIC QUERIES Yara Backes
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Mermaid Medical
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD14-jan-2016 - 7-feb-2016


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