TumorsNCT02329665
Data Collection in Patients Undergoing CT-Guided Needle Interventions for NeedleWays System Development
A study testing NeedleWays™ System in people with Tumors, run by NeedleWays.
Trial summary
The primary objective of this study is to collect CT images of patients undergoing CT Guided Needle Intervention Procedures which will be used for the development of the NeedleWaysTM System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- NeedleWays™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to May 2016
- 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
- Male or female subjects, 18 years of age or older at the time of enrollment.
- Subjects meeting all medical conditions for percutaneous CT-guided needle intervention.
- INR <1.4
- Written informed consent to participate in the study.
- Ability to comply with the requirements of the study procedures. Exclusion Criteria
- Subjects diagnosed with one or more of the following according to medical records:
Show all 16Show fewer
- Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting,Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
- Subjects treated with Ticlopidine or similar antithrombotic medication.
- Subjects who cannot tolerate mild sedation
- Subjects with the following laboratory values, unless otherwise approved by hematologist:
- Platelet count <60,000/ml
- APTT >39 sec or PT >15 sec
- Pregnancy or lactation
- Subject is unable to comply with requirements of the procedure, i.e. holding breath.
- Subject participation in an investigational trial within 30 days of enrollment
- Subjects who are uncooperative or cannot follow instructions
Who cannot join
None listed.
About this study
Official title: A Prospective Data Collection, Single-Center, Open Label Study in Patients Undergoing CT-Guided Needle Interventions for the Development of the NeedleWays System
The primary objective of this study is to collect CT images of patients undergoing CT Guided Needle Intervention Procedures which will be used for the development of the NeedleWaysTM System.
Read the detailed description
The study will collect anonymized data in support of further development of the NeedleWays System.
The collected data will be:
- Anonymized CT scans with Patient Reference Frame (PRF) placed upon the scanned area, outside of the sterile field.
- Screen captures of the NeedleWays Procedure console display as the intervention needle is placed on the patients body, outside of the sterile field.
- Conditions
- Tumors
- Being tested
- NeedleWays™ System
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeedleWays™ SystemDevice
A total of 50 consecutive subjects scheduled for clinically indicated CT guided needle intervention procedure will be invited to enroll in the study.
| Study group | Role | What they receive |
|---|---|---|
| NeedleWays™ System | Experimental | A total of 50 consecutive subjects scheduled for clinically indicated CT guided needle intervention procedure will be invited to enroll in the study. Receives: Device: NeedleWays™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
collect CT images of patients undergoing CT
The primary objective of this study is to collect CT images of patients undergoing CT Guided Needle Intervention Procedures which will be used for the development of the NeedleWaysTM System.
Measured: procedure duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeedleWays
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329665
- Sponsor's protocol ID
- NW-CL-001P-IL
- Status last verified
- Dec 2014
- First submitted
- 20 Dec 2014
- Last updated
- 1 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Data Collection, Single-Center, Open Label Study in Patients Undergoing CT-Guided Needle Interventions for the Development of the NeedleWays System
- ClinicalTrials.gov ID
- NCT02329665
- Acronym / sponsor ID
- NW-CL-001P-IL
- Conditions
- Tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NeedleWaysUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 1 Jan 2015 (estimated)
- 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 primary objective of this study is to collect CT images of patients undergoing CT Guided Needle Intervention Procedures which will be used for the development of the NeedleWaysTM System.
Detailed description
The study will collect anonymized data in support of further development of the NeedleWays System.
The collected data will be:
- Anonymized CT scans with Patient Reference Frame (PRF) placed upon the scanned area, outside of the sterile field.
- Screen captures of the NeedleWays Procedure console display as the intervention needle is placed on the patients body, outside of the sterile field.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeedleWays™ System | Experimental | Device: NeedleWays™ SystemA total of 50 consecutive subjects scheduled for clinically indicated CT guided needle intervention procedure will be invited to enroll in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female subjects, 18 years of age or older at the time of enrollment.
- Subjects meeting all medical conditions for percutaneous CT-guided needle intervention.
- INR <1.4
- Written informed consent to participate in the study.
- Ability to comply with the requirements of the study procedures. Exclusion Criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| NeedleWays™ SystemA total of 50 consecutive subjects scheduled for clinically indicated CT guided needle intervention procedure will be invited to enroll in the study. | Device | NeedleWays™ System |
Primary outcome
collect CT images of patients undergoing CT
Time frame: procedure duration
The primary objective of this study is to collect CT images of patients undergoing CT Guided Needle Intervention Procedures which will be used for the development of the NeedleWaysTM System.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2015.
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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 NeedleWays™ System in people with Tumors, run by NeedleWays.
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 16 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 1 Jan 2015. 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?
Results are not available in the source record.
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?
collect CT images of patients undergoing CT (time frame: procedure duration). 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 1 Jan 2015.