Non Invasive Monitoring of Loss of Resistance During Epidural InjectionNCT03589391
New Mechatronic Device for Epidural Space Detection
A study testing LOR measurement via device in people with Non Invasive Monitoring of Loss of Resistance During Epidural Injection, run by Campus Bio-Medico University at 2 sites in Italy.
Trial summary
This study sought to perform the feasibility assessment of a new, non-invasive device for Loss of Resistance (LOR) detection in clinical settings. The device in charge is a mechatronic device optimized in its configurations in order to detect Loss of Resistance while performing epidural injections. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non Invasive Monitoring of Loss of Resistance During Epidural Injection
- What is being tested?
- LOR measurement via device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2017to 4 Jul 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients whose pathology requires specific treatment such as epidural infiltration
Who cannot join
- coagulation abnormalities or assumption of anticoagulant drugs
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Campus Bio Medico
Rome, RM, 00128
University Hospital Campus BioMedico
Rome, 00128
About this study
Official title: A New Pressure Guided Mechatronic Tool for Epidural Space Detection: Feasibility Assessment in a Clinical Scenario
This study sought to perform the feasibility assessment of a new, non-invasive device for Loss of Resistance (LOR) detection in clinical settings. The device in charge is a mechatronic device optimized in its configurations in order to detect Loss of Resistance while performing epidural injections.
- Being tested
- LOR measurement via device
- Keywords
- Epidural injection, loss of resistance detection, mechatronic device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOR measurement via deviceDevice
The epidural technique is totally performed in a sterile field without any harm to the patient. The LOR measurement is monitored via the bespoke device used during the epidural procedure.
| Study group | Role | What they receive |
|---|---|---|
| Procedures with the use of device for LOR monitoring | Experimental | Patients enrolled suffered from chronic back pain and underwent epidural infiltration. The device is used. Receives: Device: LOR measurement via device |
| Procedures without the use of device for LOR monitoring | No intervention | Patients enrolled suffered from chronic back pain and underwent epidural infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of resistance detection
A non invasive device to detect loss of resistance during epidural infiltration
Measured: throughout the epidural infiltration procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Sep 2017
- Primary completion23 Dec 2017
- Study completion4 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non Invasive Monitoring of Loss of Resistance During Epidural InjectionStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimiliano Carassiti, Campus Bio-Medico University
- Investigators
- Massimiliano Carassiti, MD, Principal investigator, University Campus Bio-Medico of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589391
- Sponsor's protocol ID
- EPISENS
- Status last verified
- Jul 2018
- First submitted
- 6 Jul 2018
- Last updated
- 20 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tesei M, Saccomandi P, Massaroni C, Quarta R, Carassiti M, Schena E, Setola R. A cost-effective, non-invasive system for pressure monitoring during epidural needle insertion: Design, development and bench tests. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:194-197. doi: 10.1109/EMBC.2016.7590673.
PubMed 28268312Carassiti M, Biselli V, Cecchini S, Zanzonico R, Schena E, Silvestri S, Cataldo R. Force and pressure distribution using Macintosh and GlideScope laryngoscopes in normal airway: an in vivo study. Minerva Anestesiol. 2013 May;79(5):515-24. Epub 2013 Feb 18.
PubMed 23419341Carassiti M, Mattei A, Pizzo CM, Vallone N, Saccomandi P, Schena E. Bronchial blockers under pressure: in vitro model and ex vivo model. Br J Anaesth. 2016 Sep;117 Suppl 1:i92-i96. doi: 10.1093/bja/aew120. Epub 2016 Jun 14.
PubMed 27307290Carassiti M, Mattei A, Quarta R, Massaroni C, Saccomandi P, Tesei M, Setola R, Schena E. A New Pressure Guided Management Tool for Epidural Space Detection: Feasibility Assessment on a Simulator. Artif Organs. 2017 Dec;41(12):E320-E325. doi: 10.1111/aor.13007. Epub 2017 Oct 25.
PubMed 29068081Carassiti M, Quarta R, Mattei A, Tesei M, Saccomandi P, Massaroni C, Setola R, Schena E. Ex vivo animal-model assessment of a non-invasive system for loss of resistance detection during epidural blockade. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:759-762. doi: 10.1109/EMBC.2017.8036935.
PubMed 29059983
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Pressure Guided Mechatronic Tool for Epidural Space Detection: Feasibility Assessment in a Clinical Scenario
- ClinicalTrials.gov ID
- NCT03589391
- Acronym / sponsor ID
- EPISENS
- Keywords
- Epidural injection, loss of resistance detection, mechatronic device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 23 Dec 2017 (actual)
- Study completion
- 4 Jul 2018 (actual)
- First posted
- 17 Jul 2018 (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.
This study sought to perform the feasibility assessment of a new, non-invasive device for Loss of Resistance (LOR) detection in clinical settings. The device in charge is a mechatronic device optimized in its configurations in order to detect Loss of Resistance while performing epidural injections.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procedures with the use of device for LOR monitoring | Experimental | Device: LOR measurement via devicePatients enrolled suffered from chronic back pain and underwent epidural infiltration. The device is used. |
| Procedures without the use of device for LOR monitoring | No intervention | –Patients enrolled suffered from chronic back pain and underwent epidural infiltration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients whose pathology requires specific treatment such as epidural infiltration
Key exclusion criteria (1 listed)
- coagulation abnormalities or assumption of anticoagulant drugs
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 |
|---|---|---|
| LOR measurement via deviceThe epidural technique is totally performed in a sterile field without any harm to the patient. The LOR measurement is monitored via the bespoke device used during the epidural procedure. | Device | Procedures with the use of device for LOR monitoring |
Primary outcome
Loss of resistance detection
Time frame: throughout the epidural infiltration procedure
A non invasive device to detect loss of resistance during epidural infiltration
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 20 Jul 2018.
- Background: PubMed 28268312Tesei M, Saccomandi P, Massaroni C, Quarta R, Carassiti M, Schena E, Setola R. A cost-effective, non-invasive system for pressure monitoring during epidural needle insertion: Design, development and bench tests. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:194-197. doi: 10.1109/EMBC.2016.7590673.
- Background: PubMed 23419341Carassiti M, Biselli V, Cecchini S, Zanzonico R, Schena E, Silvestri S, Cataldo R. Force and pressure distribution using Macintosh and GlideScope laryngoscopes in normal airway: an in vivo study. Minerva Anestesiol. 2013 May;79(5):515-24. Epub 2013 Feb 18.
- Background: PubMed 27307290Carassiti M, Mattei A, Pizzo CM, Vallone N, Saccomandi P, Schena E. Bronchial blockers under pressure: in vitro model and ex vivo model. Br J Anaesth. 2016 Sep;117 Suppl 1:i92-i96. doi: 10.1093/bja/aew120. Epub 2016 Jun 14.
- Background: PubMed 29068081Carassiti M, Mattei A, Quarta R, Massaroni C, Saccomandi P, Tesei M, Setola R, Schena E. A New Pressure Guided Management Tool for Epidural Space Detection: Feasibility Assessment on a Simulator. Artif Organs. 2017 Dec;41(12):E320-E325. doi: 10.1111/aor.13007. Epub 2017 Oct 25.
- Background: PubMed 29059983Carassiti M, Quarta R, Mattei A, Tesei M, Saccomandi P, Massaroni C, Setola R, Schena E. Ex vivo animal-model assessment of a non-invasive system for loss of resistance detection during epidural blockade. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:759-762. doi: 10.1109/EMBC.2017.8036935.
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.
Massimiliano Carassiti, MD principal investigator
University Campus Bio-Medico of Rome
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOR measurement via device in people with Non Invasive Monitoring of Loss of Resistance During Epidural Injection, run by Campus Bio-Medico University at 2 sites in Italy.
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 20 Jul 2018. 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 Italy. 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?
Loss of resistance detection (time frame: throughout the epidural infiltration procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03589391, which also lists 5 linked publications.
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 20 Jul 2018.