Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy

November 17, 2014 updated by: superDimension Ltd.

Open Label, Randomized, Comparative, Single Center, Pilot Study to Assess the Added Value of inReach Technology Software on Performance Characteristics of Standard Bronchoscopy.

The study is aimed to evaluate and describe the added value of inReach planning software on performance characteristics of standard bronchoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Pulmonology Department, Tel Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Candidates for non-emergency bronchoscopy
  • Must provide signed informed consent
  • Male or female above 18 years old
  • Lung lesions up to 3 cm in size (in largest diameter), non-visible by standard bronchoscope

Exclusion Criteria:

  • CT done over a month before the bronchoscopy procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: inReach (A)
Bronchoscopy procedure is planned using inReach planning software
Device: inReach bronchoscopy planning software
inReach planning software creates three-dimensional lung CT reconstruction, enabling rapid virtual endoscopic depiction of the airways that allows to plan bronchoscopy virtually.
Active Comparator: Control (B)
Bronchoscopy procedure is planned using standard CT viewer software
Device: Standard lung CT viewer
CT viewer, used for standard bronchoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bronchoscopy Diagnostic Yield, compared between two study groups and calculated as percentage of true diagnoses from total number of bronchoscopy procedures.
Time Frame: Until the definitive diagnosis is obtained
Until the definitive diagnosis is obtained

Secondary Outcome Measures

Outcome Measure
Time Frame
Bronchoscopy Safety Profile, compared between two groups and calculated as percentage of bronchoscopy-related adverse events.
Time Frame: At discharge from bronchoscopy unit
At discharge from bronchoscopy unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

superDimension Ltd.

Investigators

  • Principal Investigator: Avi Mann, MD, Pulmonology Department, Tel Aviv Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 1, 2009

First Submitted That Met QC Criteria

January 5, 2009

First Posted (Estimate)

January 6, 2009

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPR0006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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