Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
NCT ID:
NCT07185295
Eligibility Criteria:
Inclusion Criteria:
* Age over 18 years.
* Patients scheduled for elective outpatient colonoscopy for any indication, in whom removal of colorectal polyps will be performed if identified during the procedure.
* Anticoagulant treatment with vitamin K antagonists (acenocoumarol or warfarin) or direct oral anticoagulants (dabigatran, edoxaban, apixaban, or rivaroxaban) prior to the colonoscopy.
Exclusion Criteria:
* Concomitant antiplatelet therapy.
Age over 85 years.
Urgent colonoscopy.
Labile INR (time in therapeutic range less than 60%) documented in the previous 3 months in patients receiving VKAs.
Supratherapeutic INR (\>3.5) at the time of the procedure in patients on VKAs.
Pregnancy.
Decompensated liver cirrhosis.
Inability, at the investigator's discretion, to understand the periprocedural anticoagulation regimen.
Known coagulopathy or bleeding diathesis, including platelet count \<50,000/µl in the previous 12 months.
Scheduled endoscopic dilation.
Severe psychiatric disorder.
Removal of colorectal lesions by endoscopic submucosal dissection.
Previous diagnosis of renal failure defined as creatinine \>2 mg/dl or clearance \<30 ml/min.
Planned high bleeding risk procedure during simultaneous gastroscopy.
Previous inclusion in the trial. Patients may only be included once.
Patients who are not candidates for a second endoscopic intervention due to clinical conditions.
Any clinical situation or concomitant treatment that, in the investigator's opinion, poses a significant bleeding risk.
Patients with polyps larger than 4 cm pending endoscopic resection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07185295
Study Brief:
Protocol Section:
NCT07185295