- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03231046
Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/CBCT) (MANIFOLD II)
July 25, 2017 updated by: Clear Guide Medical
The objective of this research is to evaluate functional validation of the CBCT-US fusion for the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system performance.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Human subjects are proposed to validate the CBCT-US fusion aspects of the Clear Guide SCENERGY product.
For these modalities, Clear Guide Medical will work with the subcontract PI to determine the appropriate clinical procedure to evaluate (1) functional validation of the fusion system and (2) benefits derived from system performance.
The selected procedure must be a single-patient interaction (i.e., no follow-up visits).
Clinical studies will require approval through the subcontract's IRB.
The Clear Guide SCENERGY will be compared to standard clinical practice (either no fusion or an electromagnetic-based fusion system).
Clear Guide Medical plans to determine sample size based upon statistical powering for a predetermined clinically-meaningful difference (delta).
This delta has not been selected, because this depends on the procedure selected.
The anticipated sample size is expected to be around 100 subjects (i.e., 50 per arm), per modality.
Blinding will be used, where possible.
Clinician-related endpoints cannot be blinded due to obvious equipment differences.
Subjects will be placed into treatment group by random.
Retention strategies are unnecessary, as there will not be any planned follow-up visits or activities.
Study Type
Interventional
Phase
- Not Applicable
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:
- Undergoing radiological, oncological, or urological intervention procedures
- Able to give written informed consent
Exclusion Criteria:
- Unable to give informed consent
- Vulnerable populations and children
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
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBCT-US Fusion Arm
Clear Guide SCENERGY, CBCT-US
|
Use of Clear Guide SCENERGY for CBCT-US fusion guidance
Other Names:
|
Active Comparator: EM Fusion or No Fusion Arm
|
Standard of Care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success of needle placement
Time Frame: Immediately following intervention (within 2 hours)
|
Distance between needle tip and target
|
Immediately following intervention (within 2 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Anticipated)
April 1, 2018
Primary Completion (Anticipated)
March 1, 2019
Study Completion (Anticipated)
March 1, 2019
Study Registration Dates
First Submitted
July 12, 2016
First Submitted That Met QC Criteria
July 25, 2017
First Posted (Actual)
July 27, 2017
Study Record Updates
Last Update Posted (Actual)
July 27, 2017
Last Update Submitted That Met QC Criteria
July 25, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- CGM 18-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
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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