Renal Biopsy or AblationMANIFOLD INCT03232385
Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/MR)
A study testing MR-US Fusion Arm and Renal Biopsy or Ablation in people with Renal Biopsy or Ablation, run by Clear Guide Medical.
Trial summary
The objective of this research is to evaluate functional validation of the MR-US fusion for the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Biopsy or Ablation
- What is being tested?
- MR-US Fusion Arm and Renal Biopsy or Ablation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing radiological, oncological, or urological intervention procedures
- Able to give written informed consent
Who cannot join
- Unable to give informed consent
- Vulnerable populations and children
About this study
The objective of this research is to evaluate functional validation of the MR-US fusion for the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system performance.
Read the detailed description
Human subjects are proposed to validate the MR-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.
- Conditions
- Renal Biopsy or Ablation
- Being tested
- MR-US Fusion Arm, Renal Biopsy or Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-US Fusion ArmDevice
Also called Clear Guide SCENERGY, MR-US
Use of Clear Guide SCENERGY for MR-US fusion guidance
Renal Biopsy or AblationProcedure or surgery
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| MR-US Fusion Arm | Experimental | Clear Guide SCENERGY, MR-US Receives: Device: MR-US Fusion Arm |
| EM Fusion or No Fusion Arm | Active comparator | Not described Receives: Procedure: Renal Biopsy or Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Needle Placement
Distance between needle position and target
Measured: Immediately following intervention (within 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start1 Apr 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Biopsy or AblationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clear Guide Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232385
- Sponsor's protocol ID
- CGM 18-001
- Acronym
- MANIFOLD I
- Status last verified
- Jul 2017
- First submitted
- 12 Jul 2016
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/MR)
- ClinicalTrials.gov ID
- NCT03232385
- Acronym / sponsor ID
- MANIFOLD I / CGM 18-001
- Conditions
- Renal Biopsy or Ablation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Clear Guide MedicalIndustry (pharma, biotech, devices)
- Collaborators
- University of Maryland
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this research is to evaluate functional validation of the MR-US fusion for the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system performance.
Detailed description
Human subjects are proposed to validate the MR-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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MR-US Fusion Arm | Experimental | Device: MR-US Fusion ArmClear Guide SCENERGY, MR-US |
| EM Fusion or No Fusion Arm | Active comparator | Procedure: Renal Biopsy or Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing radiological, oncological, or urological intervention procedures
- Able to give written informed consent
Key exclusion criteria (2 listed)
- Unable to give informed consent
- Vulnerable populations and children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-US Fusion ArmAlso: Clear Guide SCENERGY, MR-USUse of Clear Guide SCENERGY for MR-US fusion guidance | Device | MR-US Fusion Arm |
| Renal Biopsy or AblationStandard of Care | Procedure or surgery | EM Fusion or No Fusion Arm |
Primary outcome
Success of Needle Placement
Time frame: Immediately following intervention (within 2 hours)
Distance between needle position and target
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MR-US Fusion Arm and Renal Biopsy or Ablation in people with Renal Biopsy or Ablation, run by Clear Guide Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of Needle Placement (time frame: Immediately following intervention (within 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017; AzTrials last refreshed its copy on 27 Oct 2026.