Epidural LocalizationNCT03983109
EpiFaith Syringe for Epidural Space Detection
A study testing EpiFaith loss of resistance detect syringe in people with Epidural Localization, run by Flat Medical Co., Ltd at 1 site in Taiwan.
Trial summary
The objective of the study is to verify the efficacies of both air and saline based procedure of EpiFaith syringe for assisting the needle localization of the epidural space. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epidural Localization
- What is being tested?
- EpiFaith loss of resistance detect syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Apr 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 years and older
- Surgery requiring epidural anesthesia or analgesia
- ASA Physical Status 1 to 3
Who cannot join
- Bleeding and clotting disorders
- Platelet count < 100,000 / mm3
- International normalized ratio (INR) > 1.5
- History of peripheral neuropathy
- Neuromuscular or neuropsychiatric disease
- Marked spinal deformities or a history of spinal instrumentation
Show all 9Show fewer
- Systemic infection
- Skin infection at the injection site
- Significant heart failure, e.g. New York Heart Association (NYHA) Functional Classification 3 or 4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identify the Epidural Space With EpiFaith Syringe in Air and Saline Based Procedures
The objective of the study is to verify the efficacies of both air and saline based procedure of EpiFaith syringe for assisting the needle localization of the epidural space.
Read the detailed description
This is a single blind, randomized study. Subjects who will receive a surgery requiring epidural anesthesia or analgesia and meet all of the study criteria will be enrolled in the study. All subjects must sign an informed consent and receive a copy of the signed and dated informed consent form prior to participation in the trial.
The study consists of 2 study visits: Visit 1 (Screening Visit) and Visit 2 (Operative Visit). After screening, eligible subject will be randomly assigned to one of the following groups: Group A: detection by EpiFaith syringe with air; Group S: detection by EpiFaith syringe with saline with a 1:1 ratio. In Visit 2, the following variables will be recorded and rated during the process of epidural space localization: Success of epidural localization, time to identify the epidural space, duration of the epidural space localization procedure, number of attempts, Number of the occurrence of false positive, the distance from the skin to the epidural space, and number of change insertion segment. Adverse events and concomitant treatments will be also recorded.
- Conditions
- Epidural Localization
- Being tested
- EpiFaith loss of resistance detect syringe
- Keywords
- EpiFaith, Epidural localization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiFaith loss of resistance detect syringeDevice
An EpiFaith syringe will be used to detect the loss of resistance and facilitate the needle localization.
| Study group | Role | What they receive |
|---|---|---|
| Detection by EpiFaith syringe with air | Experimental | Fill the EpiFaith Syringe with air for LOR detection Receives: Device: EpiFaith loss of resistance detect syringe |
| Detection by EpiFaith syringe with saline | Experimental | Fill the EpiFaith Syringe with saline for LOR detection Receives: Device: EpiFaith loss of resistance detect syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Epidural Localization
Defined as the catheter can be inserted into epidural space successfully, no cold perception in the blocked dermatomes after the injection of anesthetic by cold sensation test, and no occurrence of inadvertent dural puncture.
Measured: 30 minutes
Secondary outcomes (6)
The Time to Identify the Epidural Space
Defined as the time of the successful localization from the first syringe attached to the Tuohy needle to the occurrence of LOR signal.
Measured: 30 minutes
Duration of the Epidural Space Localization Procedure
Defined as the time from the puncture of skin to the successful insertion of the epidural catheter.
Measured: 30 minutes
Number of Attempts
Defined as the insertion of the epidural catheter is unsuccessful or the perception of cold exists in the blocked dermatomes after the injection of anesthetic by cold sensation test.
Measured: 30 minutes
The Distance From the Skin to the Epidural Space
Defined as the insertion distance of the needle after locating the epidural space.
Measured: 30 minutes
Number of Change Insertion Segment
Number of change insertion segment during the epidural localization procedure.
Measured: 30 minutes
Number of the Occurrence of False Positive
the insertion of the epidural catheter is unsuccessful or the perception of cold exists in the blocked dermatomes after the injection of anesthetic by cold sensation test
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start23 Apr 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epidural LocalizationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flat Medical Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chien-Kun Ting, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983109
- Sponsor's protocol ID
- EPS01
- Status last verified
- Jan 2024
- First submitted
- 10 Jun 2019
- Last updated
- 5 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identify the Epidural Space With EpiFaith Syringe in Air and Saline Based Procedures
- ClinicalTrials.gov ID
- NCT03983109
- Acronym / sponsor ID
- EPS01
- Conditions
- Epidural Localization
- Keywords
- EpiFaith, Epidural localization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Flat Medical Co., LtdUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Posted 5 Jul 2024
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 the study is to verify the efficacies of both air and saline based procedure of EpiFaith syringe for assisting the needle localization of the epidural space.
Detailed description
This is a single blind, randomized study. Subjects who will receive a surgery requiring epidural anesthesia or analgesia and meet all of the study criteria will be enrolled in the study. All subjects must sign an informed consent and receive a copy of the signed and dated informed consent form prior to participation in the trial.
The study consists of 2 study visits: Visit 1 (Screening Visit) and Visit 2 (Operative Visit). After screening, eligible subject will be randomly assigned to one of the following groups: Group A: detection by EpiFaith syringe with air; Group S: detection by EpiFaith syringe with saline with a 1:1 ratio. In Visit 2, the following variables will be recorded and rated during the process of epidural space localization: Success of epidural localization, time to identify the epidural space, duration of the epidural space localization procedure, number of attempts, Number of the occurrence of false positive, the distance from the skin to the epidural space, and number of change insertion segment. Adverse events and concomitant treatments will be also recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Detection by EpiFaith syringe with air | Experimental | Device: EpiFaith loss of resistance detect syringeFill the EpiFaith Syringe with air for LOR detection |
| Detection by EpiFaith syringe with saline | Experimental | Device: EpiFaith loss of resistance detect syringeFill the EpiFaith Syringe with saline for LOR detection |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 years and older
- Surgery requiring epidural anesthesia or analgesia
- ASA Physical Status 1 to 3
Key exclusion criteria (9 listed)
- Bleeding and clotting disorders
- History of peripheral neuropathy
- Neuromuscular or neuropsychiatric disease
- Marked spinal deformities or a history of spinal instrumentation
- Systemic infection
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 |
|---|---|---|
| EpiFaith loss of resistance detect syringeAn EpiFaith syringe will be used to detect the loss of resistance and facilitate the needle localization. | Device | Detection by EpiFaith syringe with air, Detection by EpiFaith syringe with saline |
Primary outcome
Success of Epidural Localization
Time frame: 30 minutes
Defined as the catheter can be inserted into epidural space successfully, no cold perception in the blocked dermatomes after the injection of anesthetic by cold sensation test, and no occurrence of inadvertent dural puncture.
6 secondary outcomes
The Time to Identify the Epidural Space
Time frame: 30 minutes
Duration of the Epidural Space Localization Procedure
Time frame: 30 minutes
Number of Attempts
Time frame: 30 minutes
The Distance From the Skin to the Epidural Space
Time frame: 30 minutes
Number of Change Insertion Segment
Time frame: 30 minutes
Number of the Occurrence of False Positive
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Chien-Kun Ting, MD principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EpiFaith loss of resistance detect syringe in people with Epidural Localization, run by Flat Medical Co., Ltd at 1 site in Taiwan.
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 3 inclusion and 9 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 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Epidural Localization (time frame: 30 minutes). 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 5 Jul 2024.