Anesthesia, LocalNCT03368976
PACMAN Ultrasound Recording Data Collection
An observational study of Anesthesia, Local, run by Avanos Medical at 8 sites in United States.
Trial summary
Study to collect videos of ultrasound recordings during peripheral nerve block procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local
- How many people
- 767 participants
- Where
- 8 sitesUnited States
- Study dates
- 31 Jul 2017to 17 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with planned peripheral nerve block procedures.
Who may be able to join
- Patients 18 years and older with underlying pathologies requiring surgical intervention facilitated by a specific regional nerve block
- Informed consent executed
Who cannot join
- Patients unable to understand and provide written consent
- Infection at the injection site
- Allergy to local anesthetic agents
- Medical condition obscuring visualization
- Known neuropathy at or around target nerve for the PNB
- Inability to communicate with the investigator or hospital staff
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Christ Hospital
Cincinnati, Ohio, 45245
Duke University
Durham, North Carolina, 27710
Andrews Institute
Gulf Breeze, Florida, 32561
Indiana University
Indianapolis, Indiana, 46202
University of Miami
Miami, Florida, 33136
University of Minnesota - Twin Cities
Minneapolis, Minnesota, 55455
Universal Medical Resources
Troy, Michigan, 48098
George Washington University
Washington D.C., District of Columbia, 20037
About this study
Official title: Prospective, Multicenter, Single Arm Feasibility Study to Collect Patient and Imaging Data for Avanos Medical Ultrasound Guided Regional Anesthesia System Development
Study to collect videos of ultrasound recordings during peripheral nerve block procedures.
- Conditions
- Anesthesia, Local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Interscalene | Not described | |
| Supraclavicular | Not described | |
| Infraclavicular | Not described | |
| Transversus Abdominus Plane | Not described | |
| Paravertebral Space | Not described | |
| Fascia Iliaca | Not described | |
| Femoral Nerve | Not described | |
| Saphenous Nerve via Adductor Canal | Not described | |
| Popliteal Sciatic Nerve | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of ultrasound recordings
Collection of 100 ultrasound recordings for each group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start31 Jul 2017
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Why it stopped: Interim Goals met. Decision made to terminate in favor of completing the study as a second protocol in the future.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 767 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avanos Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368976
- Sponsor's protocol ID
- 101-17-0001
- Status last verified
- Sep 2019
- First submitted
- 6 Dec 2017
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single Arm Feasibility Study to Collect Patient and Imaging Data for Avanos Medical Ultrasound Guided Regional Anesthesia System Development
- ClinicalTrials.gov ID
- NCT03368976
- Acronym / sponsor ID
- 101-17-0001
- Conditions
- Anesthesia, Local
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Interim Goals met. Decision made to terminate in favor of completing the study as a second protocol in the future.
- Enrolment
- 767 participants (actual)
- Lead sponsor
- Avanos MedicalUniversity, hospital or other
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 11 Dec 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.
Study to collect videos of ultrasound recordings during peripheral nerve block procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Interscalene | – | – |
| Supraclavicular | – | – |
| Infraclavicular | – | – |
| Transversus Abdominus Plane | – | – |
| Paravertebral Space | – | – |
| Fascia Iliaca | – | – |
| Femoral Nerve | – | – |
| Saphenous Nerve via Adductor Canal | – | – |
| Popliteal Sciatic Nerve | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with planned peripheral nerve block procedures.
Key inclusion criteria (2 listed)
- Patients 18 years and older with underlying pathologies requiring surgical intervention facilitated by a specific regional nerve block
- Informed consent executed
Key exclusion criteria (6 listed)
- Patients unable to understand and provide written consent
- Infection at the injection site
- Allergy to local anesthetic agents
- Medical condition obscuring visualization
- Known neuropathy at or around target nerve for the PNB
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
Collection of ultrasound recordings
Time frame: 6 months
Collection of 100 ultrasound recordings for each group
Results and safety
The study was stopped early (reason given: Interim Goals met. Decision made to terminate in favor of completing the study as a second protocol in the future.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Local, run by Avanos Medical at 8 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 was stopped early (reason given: Interim Goals met. Decision made to terminate in favor of completing the study as a second protocol in the future.). 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?
Collection of ultrasound recordings (time frame: 6 months). 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 19 Sep 2019.