Study With Oral Isovue in Abdominopelvic CT

NCT ID: NCT04453059

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

218 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-07-01

Brief Summary

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This is a retrospective clinical study with prospectively designed blinded evaluation of CT images in adult and pediatric patients who underwent CT examinations of the abdomen and pelvis and were orally administered a solution of Isovue-300 to opacify the GI tract to distinguish it from adjacent abdominal and pelvic structures. The study will collect already existing data, such as demographic data, adverse events and CT images, for all chronologically enrolled patients who meet the inclusion/exclusion criteria prospectively defined in this protocol

Detailed Description

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Conditions

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Patients Requiring Abdominopelvic CT With Oral Administration of Contrast

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Iopamidol

Previously administered Isovue-300 (300 mgI/mL) PO at a dilution of 2-3% (6-9 mgI/mL)

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Oral contrast agent received within 1 week prior to the CT scan
* Undergone any abdominopelvic surgery procedure that resulted in alteration of the bowel transit time prior to the CT exam
* CT exam with oral administration of Isovue was performed because of a known or suspected condition of bowel obstruction
* Patient did not actively drink the contrast solution.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Akron Children's Hospital

Akron, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IOP-121

Identifier Type: -

Identifier Source: org_study_id

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