Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)

NCT ID: NCT01080690

Last Updated: 2010-03-04

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hypothesis: Endosonography (EUS) in a single setting is equivalent to the standard algorithm combining abdominal sonography, gastroscopy, endosonography in patients with acute right side abdominal pain.

Patients with acute right side abdominal pain will be randomized in one of two groups. In each group all examinations (sonography, gastroscopy, endosonography) will be performed. The study group only defines the order of the examinations. Abdominal sonography will always be performed before endoscopic procedures. In group 1, gastroscopy is first followed by endosonography. In group 2 endosonography is first followed by gastroscopy.

Two physicians will review all results of all examinations, patient charts as well as a follow up visit and establish a clinical diagnosis.

Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abdominal Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EGD

In this arm EGD will be performed before EUS

Group Type ACTIVE_COMPARATOR

EGD

Intervention Type PROCEDURE

In this arm EGD will be performed before EUS.

EUS

In this arm, EUS will be performed before EGD.

Group Type ACTIVE_COMPARATOR

EUS

Intervention Type PROCEDURE

In this arm EUS will be performed before EGD.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EGD

In this arm EGD will be performed before EUS.

Intervention Type PROCEDURE

EUS

In this arm EUS will be performed before EGD.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EGD: A standard diagnostic EGD will be performed. EUS: A standard diagnostic EUS will be performed.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* acute right side abdominal pain
* willing participate study

Exclusion Criteria

* acute disease
* malignancy
* other disease which might cause discomfort
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Technical University Munich

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexander Meining, Prof.

Role: PRINCIPAL_INVESTIGATOR

II Med Dep, TU Munich

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Klinikum r.d. Isar, Technical University Munich

Munich, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Valentin Becker, Dr.

Role: CONTACT

+49 89 41400

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alexander Meining, Prof.

Role: primary

+49 89 41400

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01102

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.