NCT07215000 Cleansing Options in Out-Patient Setting to Improve Tolerance (COOP SIT) Trial
| NCT ID | NCT07215000 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Morehouse School of Medicine |
| Condition | Colorectal Cancer Screening |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2025-10-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research is to compare patient preferences for two bowel preparation options: low-volume tablets (Suflave/Sutab) versus the standard colon preparation using Golytely (polyethylene glycol). The study aims to enroll approximately 300 patients, who will be randomly assigned to one of the two preparation methods in a 2:1 ratio prior to their scheduled colonoscopy appointments. Surveys will be conducted both before and after the procedures. This project will be conducted over a 12-month period and seeks to compare patient experience of both preparation methods in an outpatient setting. The study will evaluate the rate of preparation completion, patient satisfaction, tolerance of the solutions, and the endoscopic adequacy of each method. Eligible participants are patients aged 18 or older with upcoming colonoscopy appointments who can provide informed consent in English or Spanish. There is no health risks associated with this study, as both bowel preparation methods are FDA-approved and commonly used in clinical practice.
Eligibility Criteria
Inclusion Criteria: * Adults over age of 18 years undergoing outpatient colonoscopy for various indications, ability to consent in English or Spanish. Patients will still be allowed to join if there is a history of colorectal cancer or previous surgery Exclusion Criteria: * Patient is less than 18 years of age, any pregnant or nursing women, unable to consent, or patient is incarcerated.
Contact & Investigator
Jesus M Luevano, MD, MS
PRINCIPAL INVESTIGATOR
Morehouse School of Medicine
Frequently Asked Questions
Who can join the NCT07215000 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer Screening. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07215000 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07215000 currently recruiting?
Yes, NCT07215000 is actively recruiting participants. Contact the research team at jjliu@msm.edu for enrollment information.
Where is the NCT07215000 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT07215000 clinical trial?
NCT07215000 is sponsored by Morehouse School of Medicine. The principal investigator is Jesus M Luevano, MD, MS at Morehouse School of Medicine. The trial plans to enroll 300 participants.
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