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OpenTrials
Completed

NCT Number: NCT02765022

Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection.

An simple-blind, randomized study, to evaluate the efficacy and safety of complete closure with clips of mucosal defects after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal lesions (≥ 2 cm) as prophylaxis of delayed bleeding.

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Key information

Conditions

Endoscopic Resection Clip Haemorrhage Hemorrhage Non-pedunculated Lesions Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eduardo Albeniz Arbizu

Pamplona, Navarre, 31008, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years and older
  • Clinical indication of endoscopic mucosal resection for large-sized (≥ 2cm) non-pedunculated colorectal lesions.
  • Medium-high risk of delayed bleeding (DB risk score ≥ 4)
  • Informed consent.

Exclusion criteria

  • Patients with colorectal non-pedunculated lesions without endoscopic mucosal resection indication.
  • Lesions resected by endoscopic submucosal resection.
  • Incomplete resections.
  • Resections with suspected deep submucosal invasion.
  • Mucosal defects treated with clips for known or suspected damage to the muscle layer.
  • Lesions with low risk of delayed bleeding (DB risk score ≤3).
  • Patients with any other medical, geographic or social condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.

Treatment and study plan

Clip closure

Device

Complete clip closure of secondary lesions after the endoscopic mucosal resection

No clip closure

Procedure

Observation: no clip closure of secondary lesions after the endoscopic mucosal resection

Primary outcomes

  1. Delayed hemorrhage

    Time frame: 15 days post-EMR

Sponsors and collaborators

Lead sponsor

Fundacion Miguel Servet

Other

Registry information

Official study title

Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection of Large Colorectal Lesions as Prophylaxis of Delayed Haemorrhage.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 6, 2016
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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