EFTR vs. conventional endoscopic therapy for recurrent or incompletely resected non-lifting colorectal adenomas
Organizational Data
- DRKS-ID:
- DRKS00023539
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2020-11-10
- Last update in DRKS:
- 2020-11-10
- Registration type:
- Prospective
Acronym/abbreviation of the study
CURE
URL of the study
Brief summary in lay language
EFTR vs. conventional endoscopic therapy for recurrent or incompletely resected non-lifting colorectal adenomas
Brief summary in scientific language
Randomized-controlled multicentric study to compare EFTR vs. conventional endoscopic therapy for recurrent or incompletely resected non-lifting colorectal adenomas
Health condition or problem studied
- ICD10:
- D12.0 - Caecum
- ICD10:
- D12.2 - Ascending colon
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- EFTR with FTRD, hybrid technique allowed
- Arm 2:
- resection with conventional techniques (EMR, Avulsion, thermal therapy)
Endpoints
- Primary outcome:
- Residual or recurrent adenoma at 12 months
- Secondary outcome:
- technical success complete resection procedure time necessity of surgery recurrence rate after 6 months and 3-5years adverse events
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Switzerland
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Medizinische Klinik II Freiburg im Breisgau
- University medical center Mannheim
- Medical center St Vinzenz KH Köln
- Medical center Triemli Spital Zürich
- Medical center EVK Düsseldorf
- University medical center Marburg
- Medical center Klinikum Ludwigsburg Ludwigsburg
- University medical center Ulm
- University medical center Augsburg
- Medical center Kinikum Altenburger Land Altenburger Land
- University medical center Gelifswald
- Medical center Elisabethen-KH Essen
- Medical center Diakonie Klinikum Freiburg im Breisgau
- University medical center UKE Hamburg
- Medical center Klinik Neuperlach
Recruitment period and number of participants
- Planned study start date:
- 2020-11-16
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 222
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- recurrent or residual adenoma after previous endoscopic resection in the colorectum
Exclusion Criteria
age <18 years histological evidence of carcinoma or high probability of carcinoma stenosis in the colorectum lesion size >3cm and <5 mm location of lesion in lower rectum (0-3 cm from anus)
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum FreiburgHugstetter Strasse 4979095 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum FreiburgProf. Dr. Arthur SchmidtHugstetter Strasse 5579106 FreiburgGermany
- Telephone:
- 0761-27025424
- Fax:
- 0761-27025411
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
Contact for Public Queries
- Address:
- Universitätsklinikum FreiburgProf. Dr. Arthur SchmidtHugstetter Strasse 4979095 FreiburgGermany
- Telephone:
- 0761-27025424
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
Principal Investigator
- Address:
- Universitätsklinikum FreiburgProf. Dr. Arthur SchmidtHugstetter Strasse 5579106 FreiburgGermany
- Telephone:
- 0761-27025424
- Fax:
- 0761-27025411
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Ovesco EndoscopyFriedrich Miescher Strasse 972026 TübingenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-12-18
- Ethics committee number:
- 626/19
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-08-25
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- n.a.
Study protocol and other study documents
- Study protocols:
- Studienprotokoll
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry