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Authors
Zachou, M. https://orcid.org/0000-0001-5156-9553
Varytimiadis, K.
Androutsakos, T.
Katsaras, G.
Zoumpouli, C.
Lalla, E.
Nifora, M.
Karantanos, P.
Nikiteas, N.
Sougioultzis, S.
Kalaitzakis, E.
Kykalos, S.
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Clinical Trials BETA
Clinical trials referenced in this document:
nct05273697 at ClinicalTrials.govDocuments that mention this clinical trial
Protocol design for randomized clinical trial to compare underwater cold snare polypectomy to conventional cold snare polypectomy for non-pedunculated colon polyps of size 5–10 mm (COLDWATER study)
https://doi.org/10.1007/s10151-022-02731-9
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Article History
Received: 14 May 2022
Accepted: 11 November 2022
First Online: 18 November 2022
Declarations
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: The authors declare no conflict of interest.
: The study protocol is approved by the Institutional Review Board of Sismanogleio General Hospital of Athens (PN25771/23–11-2021) and by the Committee of Bioethics and Ethics of the Medical School—National and Kapodistrian University of Athens (PN526/25–02-2022).
: The study design conforms to ICH–GCP, the Declaration of Helsinki, and local ethical and legal requirements. The study protocol is approved by the Institutional Review Board (IRB) of Sismanogleio General Hospital of Athens (PN25771/23–11-2021) and by the Committee of Bioethics and Ethics of the Medical School—National and Kapodistrian University of Athens (PN526/25–02-2022). This trial protocol was written in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). The study was registered with Clinical Trials.gov (NCT 05,273,697). All investigators and IRBs/Ethics committees will be informed by phone and e-mail in case of significant modifications of the protocol parameters.
: IRB-approved, written informed consent (witnessed, where required by law or regulation) will be obtained from all participants during the visit at the out-patient clinic before enrollment in the study. Consent forms will be given to the patients by physicians (endoscopists) who participate as investigators in the study. Patients will have enough time to read the consent form, and after that, physicians will explain in detail the study procedures and answer any question. All participants will take a copy document, and the original document will be kept as one of the essential documents for the trial master file.
: All patients will complete a written consent to participate in the study, after being thoroughly informed about the procedures.
: The study results and outcomes will be submitted for publication to an international medical journal and presented in medical conferences related to colorectal disease, interventional gastrointestinal endoscopy, and polypectomy techniques.
