Hydrocephalus Shunt (proGAV) Requiring AdjustmentX-AMINNCT01885468
X-Ray Verified Accuracy of the proGAV Verification Instrument
An observational study of Hydrocephalus Shunt (proGAV) Requiring Adjustment, run by Aesculap, Inc. at 2 sites in United States.
Trial summary
This study is to verify the use of a hand held tool to verify the new setting of a hydrocephalus shunt (proGAV). This tool would be used in place of an Xray of the patient's head, which is how settings are verified currently. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus Shunt (proGAV) Requiring Adjustment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2013to Jun 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hydrocephalus patients implanted with proGAV shunt requiring adjustment
Who may be able to join
- Implanted with proGAV Requiring adjustment Implant must be palpable under the skin
Who cannot join
- Unwilling to consent Implanted within 7 days of inclusion visit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Geisinger Medical Center
Danville, Pennsylvania, 17822
Valley Children's Hospital
Madeira, California, 93636-8762
About this study
Official title: X-Ray Verified Accuracy of the Aesculap - Miethke proGAV Adjustable Shunt Pressure Setting Verification Instrument
This study is to verify the use of a hand held tool to verify the new setting of a hydrocephalus shunt (proGAV). This tool would be used in place of an Xray of the patient's head, which is how settings are verified currently.
- Keywords
- Hydrocephalus shunt, proGAV
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of agreement between the proGAV® verification instrument measurement and X-ray control measurements.
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydrocephalus Shunt (proGAV) Requiring AdjustmentStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885468
- Sponsor's protocol ID
- AAG-G-H-1106
- Acronym
- X-AMIN
- Status last verified
- Jan 2017
- First submitted
- 21 Jun 2013
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- X-Ray Verified Accuracy of the Aesculap - Miethke proGAV Adjustable Shunt Pressure Setting Verification Instrument
- ClinicalTrials.gov ID
- NCT01885468
- Acronym / sponsor ID
- X-AMIN / AAG-G-H-1106
- Keywords
- Hydrocephalus shunt, proGAV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aesculap, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Jun 2013 (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.
This study is to verify the use of a hand held tool to verify the new setting of a hydrocephalus shunt (proGAV). This tool would be used in place of an Xray of the patient's head, which is how settings are verified currently.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hydrocephalus patients implanted with proGAV shunt requiring adjustment
Key inclusion criteria (1 listed)
- Implanted with proGAV Requiring adjustment Implant must be palpable under the skin
Key exclusion criteria (1 listed)
- Unwilling to consent Implanted within 7 days of inclusion visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of agreement between the proGAV® verification instrument measurement and X-ray control measurements.
Time frame: 1day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus Shunt (proGAV) Requiring Adjustment, run by Aesculap, Inc. at 2 sites in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Level of agreement between the proGAV® verification instrument measurement and X-ray control measurements. (time frame: 1day). 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 27 Jan 2017.