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 @ 12:50 PM
Ignite Modification Date:
2025-12-24 @ 12:50 PM
NCT ID:
NCT06522061
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years - male or female.
* Subject/SDM understands and has voluntarily signed and dated Informed Consent Form (ICF).
* Subject underwent colorectal surgery with anastomosis.
* Subjects must be willing to comply with trial requirements.
* Subject has a prophylactic abdominal/pelvic drain after colorectal surgery.
Exclusion Criteria:
* Subjects/caregiver is unwilling or unable to comply with the requirements of the protocol.
* 24 hours or more have passed since the end of the subject's surgery and consent was not attained.
* The subject had already developed an anastomotic leak at the time of screening and underwent surgery for treatment of the complication.
* Plans that the subject will be discharged in less than 3 days post-surgery.
* Subject has reported that they are pregnant.
* Subject has a permanent end stoma.
* Subject is delirious.
* Subject has severe dementia.
* Subject was involved in the planning and conduct of the clinical investigation.
* Origin™ is not compatible with the drain used on the subject.
* Subject and/or caregiver is/are not capable of conducting the calibrations for Stream™ Platform (this can be self-reported or determined by the CRC/HCP/other research staff).
* The subject and/or caregiver is/are unable to understand the instructions provided for the management and calibration of Stream™ Platform (this can be self-reported or determined by the CRC/investigator/other research staff).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06522061
Study Brief:
Protocol Section:
NCT06522061