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NCT04582500 · ClinicalTrials.gov registry record
Virtual Colonoscopy Using Omnipaque as a Contrast Agent
A clinical trial, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- 50
- Enrollment target
NCT04582500 is a clinical trial that has completed, run by Montefiore Medical Center. The registered enrollment target is 50 participants.
The verdict
NCT04582500 has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
CT colonography (CTC) is a validated screening exam for colorectal cancer. The diagnostic accuracy of CTC depends on the quality of the bowel cleansing and contrast tagging of residual stool and fluid. New bowel preparation media for CTC should be assessed for their efficacy and for patient satisfaction. Iohexol is currently approved by the FDA for oral use for imaging of the gastrointestinal tract. A potential advantage of using iohexol for CTC is that low-and iso-osmolar oral contrast agents have fewer risks than hyperosmolar contrast agents, which make them ideal for use in all patients, especially those who are frail and/or have multiple co-morbidities. For example, hyperosmolar contrast agents that are accidentally aspirated into the lungs during ingestion may result in life-threatening acute pulmonary edema and severe chemical pneumonitis, which is not the case for low- and iso-osmolar contrast agents. It may even be safer to use low- or iso-osmolar contrast agents for patients undergoing CTC on the same day as their incomplete colonoscopy, since they are at risk for aspiration from being sedated for their colonoscopy. Additionally, unlike hyperosmolar contrast agents, low- and iso-osmolar contrast agents do not cause sudden and massive fluid shifts, thus eliminating the risk of dangerous electrolyte imbalances.
Interventions
- DRUG Iohexol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2025-03-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04582500
The ClinicalTrials.gov registry entry for NCT04582500 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Iohexol is the first listed.
NCT04582500 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04582500 about?
NCT04582500 is a clinical study titled "Virtual Colonoscopy Using Omnipaque as a Contrast Agent". CT colonography (CTC) is a validated screening exam for colorectal cancer. The diagnostic accuracy of CTC depends on the quality of the bowel cleansing and contrast tagging of residual stool and fluid. New bowel preparation media for CTC should be assessed for their efficacy and for patient satisfac...
What is the current status of trial NCT04582500?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2021-02-15. Estimated completion is 2025-03-31.
What interventions are being tested in trial NCT04582500?
The interventions under investigation include: Iohexol (DRUG).
Who is sponsoring clinical trial NCT04582500?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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