NCT02341755

Brief Summary

This study aims to evaluate the accuracy of dual energy computerized tomography (DE-CT) in predicting the need for surgery in patients with Crohn's disease and intestinal lesions with obstructive symptoms. Patients with known Crohn's disease which were scheduled to perform abdominal CT for obstructive symptoms preformed it in a dual energy protocol and then followed for an outcome of surgery. DE-CT parameters were then compared between patients who underwent surgery and those who did not.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

1.9 years

First QC Date

January 11, 2015

Last Update Submit

January 16, 2015

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Abdominal surgery

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with known Crohn's disease undergoing abdominal CT for possible obstructive presentation

You may qualify if:

  • Age over 18 years,
  • known Crohn's disease (at least 3 moths prior)
  • obstructive symptoms
  • scheduled for abdominal CT for evaluation of symptoms (regardless of participation in the study)

You may not qualify if:

  • Pregnancy
  • Contraindication to perform CT with IV contrast media

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center affiliated with Hebrew University

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Tomer Adar, MD

    Shaare Zedek Medical Center affiliated with Hebrew University, Jerusalem, Israel.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior physician in internal medicine, senior gastroenterologist

Study Record Dates

First Submitted

January 11, 2015

First Posted

January 19, 2015

Study Start

May 1, 2012

Primary Completion

April 1, 2014

Study Completion

November 1, 2014

Last Updated

January 19, 2015

Record last verified: 2015-01

Locations

IL(1)