Primary Condition: Nerve BlockNCT07385872
Performance of a Novel Concept for Internal Fixation of a Novel Peripheral Nerve Block Catheter
A study testing Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve and Novel Internal Fixation Nerve Block Catheter - Saphenous nerve in people with Primary Condition: Nerve Block and Secondary Condition: Catheter Displacement, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
The goal of this study is to test a new type of nerve block catheter (a thin, flexible tube used to deliver pain medication). Researchers want to see if this new design stays in its original position better than current catheters and if it is easy for doctors to use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Condition: Nerve Block, Secondary Condition: Catheter Displacement, Focus of Study: Sciatic Nerve
- What is being tested?
- Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve and Novel Internal Fixation Nerve Block Catheter - Saphenous nerve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged 18 years or older
- Scheduled for elective transfemoral amputation
- Able and willing to provide informed consent
Who cannot join
- Known allergy to local anesthetics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Hvidovre Hospital
Copenhagen, Capital Region
Tazio Maleitzke, MD, PhD, +45 20141988, tazio.maleitzke@regionh.dk
About this study
Official title: Feasibility and Performance of a Novel Concept for Internal Fixation of a Peripheral Nerve Block Catheter in Patients Undergoing Femoral Amputation
The goal of this study is to test a new type of nerve block catheter (a thin, flexible tube used to deliver pain medication). Researchers want to see if this new design stays in its original position better than current catheters and if it is easy for doctors to use.
The main questions the study aims to answer are:
Read more
Does the catheter tip stay in the correct position over time without moving or slipping (dislocation)?
Can the catheter be placed quickly and accurately using the new deployment system?
Researchers will test this prototype in a small group of participants. There is no comparison group for this initial study.
Participants will:
Have the catheter placed near a nerve in their leg a few days before a scheduled femoral (leg) amputation.
Undergo imaging or checks to see if the catheter has moved.
Have the catheter removed just before their scheduled surgery.
The catheter will be placed in an area of the leg that is already scheduled to be removed during surgery. This ensures that the study carries minimal risk to the participants.
Read the detailed description
Background and Rationale Peripheral nerve blocks are a standard of care for regional anesthesia; however, traditional catheters are prone to secondary dislocation (slipping out of place), which leads to inadequate pain control. This study evaluates a novel prototype catheter designed with an internal fixation mechanism intended to secure the catheter tip at the target site. Additionally, the system utilizes a refined deployment mechanism designed for rapid and precise placement by the clinician.
Study Objective The primary objective of this pilot study is to evaluate the stability and migration rate of the catheter tip over a multi-day period. Secondarily, the study will assess the technical feasibility and speed of the deployment system.
Study Design and Safety Model This is a single-arm, non-randomized, proof-of-concept trial. To ensure maximum participant safety during the testing of this new hardware, the study utilizes a femoral amputation model.
The catheter will be placed in participants who are already scheduled for a femoral amputation. The insertion site and the final position of the catheter tip will be located distal to (below) the anticipated surgical amputation line. This ensures that the tissue involved in the study is part of the limb intended for removal, thereby minimizing any long-term risk of nerve injury or local tissue complications for the participant.
Procedures
Baseline \& Placement: Eligible participants will have the prototype catheter placed via ultrasound guidance several days prior to their scheduled surgery. The time required for deployment will be recorded.
Monitoring Period: The position of the catheter tip will be monitored at set intervals using ultrasound imaging to track any migration or dislocation from the initial placement site.
Removal: The catheter will be removed in the operating room immediately prior to the commencement of the scheduled amputation.
- Conditions
- Primary Condition: Nerve Block, Secondary Condition: Catheter Displacement, Focus of Study: Sciatic Nerve
- Being tested
- Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve, Novel Internal Fixation Nerve Block Catheter - Saphenous nerve
- Keywords
- Sciatic Nerve Block, Peripheral Nerve Catheter, Catheter Migration, Internal Fixation Device, Proof-of-Concept Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Internal Fixation Nerve Block Catheter - Sciatic NerveDevice
A peripheral nerve block catheter prototype featuring internal fixation to prevent dislocation and a rapid-deployment system.
Catheters are placed under ultrasound guidance.
Novel Internal Fixation Nerve Block Catheter - Saphenous nerveDevice
Placement of the saphenous catheter is contingent upon an amputation line that allows for placement below the surgical site (distal to the cut).
| Study group | Role | What they receive |
|---|---|---|
| Sciatic Nerve Catheter | Experimental | All participants will receive the prototype fixation catheter placed near the sciatic nerve distal to the planned amputation line. Receives: Device: Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve |
| Saphenous Nerve Catheter | Experimental | If the planned amputation line is high enough on the femur to allow for distal placement, participants will also receive a second prototype fixation catheter near the saphenous nerve. Receives: Device: Novel Internal Fixation Nerve Block Catheter - Saphenous nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter Dislocation Distance
The absolute distance (in millimeters) between the position of the catheter delivery orifice at initial placement and its position just before removal. The position is verified by ultrasound imaging using hydrodissection with a local anesthetic bolus to identify the orifice.
Measured: From initial placement (Day 0) to immediately prior to amputation surgery (typically 48-72 hours).
Secondary outcomes (7)
Time on Task
Time required for catheter placement, measured from initiation of skin disinfection to final skin fixation using a stopwatch (seconds).
Measured: At time of procedure (Day 0)
Primary Placement Success Rate
Proportion of successful primary catheter placements, defined as the accurate position of the delivery orifice verified by ultrasound
Measured: At time of procedure (Day 0)
Catheter Clinical Performance (Sensory Block)
Sensitivity to a cooled vial (5°C) over the cutaneous innervation area (Tibial/Peroneal for sciatic; Saphenous for saphenous nerve).
Measured: Day 0 (preprocedure and postprocedure), day 1, day 2, and day 3.
Catheter Retraction Force
The force required for catheter removal, measured with a digital handheld force transducer (Newtons).
Measured: Day 3 (just before surgery)
Pain Intensity (NRS)
Participant-reported pain at rest using a Numeric Rating Scale (0-10, where 0 is no pain and 10 the worst thinkable pain)
Measured: Day 0, Day 1, Day 2 and Day 3
Cumulative Opioid Consumption
Total intravenous (IV) morphine equivalents administered while the catheter is in place.
Measured: Day 0 to day 3 (Entire study duration)
Incidence of Adverse Events
Number and nature of complications including infection, back-leakage, or device-related issues.
Measured: Day 0 to day 3 (Entire study duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionNov 2026 (estimated)
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 Primary Condition: Nerve BlockStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital, Nordstar Medical
- Responsible party
- Sponsor
- Investigators
- Christoffer C Jørgensen, MD, PhD, Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385872
- Sponsor's protocol ID
- Ethical Committee nr: 16098489
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Whether individual participant data will be shared has not yet been determined. The study evaluates novel design principles and mechanical fixation mechanisms for which intellectual property (IP) protection is currently being sought or finalized. A decision regarding the sharing of de-identified data will be made once the proprietary interests of the device design are fully secured and the primary feasibility analysis is complete.
Publications
Carvalho BY, Mariano ER. Continuous vs. single-injection peripheral nerve blocks: A prospective cohort study comparing procedural time and personnel cost. Open Anesthesiol J. 2015;9:1-5.
Martin N, Davis CJ. Evidence from masked-priming that initial identification of brand names is via abstract letter identities. Br J Psychol. 2019 Nov;110(4):745-768. doi: 10.1111/bjop.12362. Epub 2019 Jan 4.
PubMed 30613945Baillie J, Lankshear A. PATIENTS' AND RELATIVES' EXPERIENCES OF PERITONITIS WHEN USING PERITONEAL DIALYSIS. J Ren Care. 2015 Sep;41(3):177-86. doi: 10.1111/jorc.12118. Epub 2015 Feb 27.
PubMed 25727142Hauritz RW, Hannig KE, Balocco AL, Peeters G, Hadzic A, Borglum J, Bendtsen TF. Peripheral nerve catheters: A critical review of the efficacy. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):325-339. doi: 10.1016/j.bpa.2019.07.015. Epub 2019 Jul 22.
PubMed 31785718Ilfeld BM. Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and Comparison With Novel, Alternative Analgesic Modalities. Anesth Analg. 2017 Jan;124(1):308-335. doi: 10.1213/ANE.0000000000001581.
PubMed 27749354
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Performance of a Novel Concept for Internal Fixation of a Peripheral Nerve Block Catheter in Patients Undergoing Femoral Amputation
- ClinicalTrials.gov ID
- NCT07385872
- Acronym / sponsor ID
- Ethical Committee nr: 16098489
- Conditions
- Primary Condition: Nerve Block, Secondary Condition: Catheter Displacement, Focus of Study: Sciatic Nerve
- Keywords
- Sciatic Nerve Block, Peripheral Nerve Catheter, Catheter Migration, Internal Fixation Device, Proof-of-Concept Study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital, Nordstar Medical
- Study start
- Feb 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 4 Feb 2026 (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.
The goal of this study is to test a new type of nerve block catheter (a thin, flexible tube used to deliver pain medication). Researchers want to see if this new design stays in its original position better than current catheters and if it is easy for doctors to use.
The main questions the study aims to answer are:
Does the catheter tip stay in the correct position over time without moving or slipping (dislocation)?
Can the catheter be placed quickly and accurately using the new deployment system?
Researchers will test this prototype in a small group of participants. There is no comparison group for this initial study.
Participants will:
Have the catheter placed near a nerve in their leg a few days before a scheduled femoral (leg) amputation.
Undergo imaging or checks to see if the catheter has moved.
Have the catheter removed just before their scheduled surgery.
The catheter will be placed in an area of the leg that is already scheduled to be removed during surgery. This ensures that the study carries minimal risk to the participants.
Detailed description
Background and Rationale Peripheral nerve blocks are a standard of care for regional anesthesia; however, traditional catheters are prone to secondary dislocation (slipping out of place), which leads to inadequate pain control. This study evaluates a novel prototype catheter designed with an internal fixation mechanism intended to secure the catheter tip at the target site. Additionally, the system utilizes a refined deployment mechanism designed for rapid and precise placement by the clinician.
Study Objective The primary objective of this pilot study is to evaluate the stability and migration rate of the catheter tip over a multi-day period. Secondarily, the study will assess the technical feasibility and speed of the deployment system.
Study Design and Safety Model This is a single-arm, non-randomized, proof-of-concept trial. To ensure maximum participant safety during the testing of this new hardware, the study utilizes a femoral amputation model.
The catheter will be placed in participants who are already scheduled for a femoral amputation. The insertion site and the final position of the catheter tip will be located distal to (below) the anticipated surgical amputation line. This ensures that the tissue involved in the study is part of the limb intended for removal, thereby minimizing any long-term risk of nerve injury or local tissue complications for the participant.
Procedures
Baseline \& Placement: Eligible participants will have the prototype catheter placed via ultrasound guidance several days prior to their scheduled surgery. The time required for deployment will be recorded.
Monitoring Period: The position of the catheter tip will be monitored at set intervals using ultrasound imaging to track any migration or dislocation from the initial placement site.
Removal: The catheter will be removed in the operating room immediately prior to the commencement of the scheduled amputation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sciatic Nerve Catheter | Experimental | Device: Novel Internal Fixation Nerve Block Catheter - Sciatic NerveAll participants will receive the prototype fixation catheter placed near the sciatic nerve distal to the planned amputation line. |
| Saphenous Nerve Catheter | Experimental | Device: Novel Internal Fixation Nerve Block Catheter - Saphenous nerveIf the planned amputation line is high enough on the femur to allow for distal placement, participants will also receive a second prototype fixation catheter near the saphenous nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or older
- Scheduled for elective transfemoral amputation
- Able and willing to provide informed consent
Key exclusion criteria (1 listed)
- Known allergy to local anesthetics
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 |
|---|---|---|
| Novel Internal Fixation Nerve Block Catheter - Sciatic NerveA peripheral nerve block catheter prototype featuring internal fixation to prevent dislocation and a rapid-deployment system. Catheters are placed under ultrasound guidance. | Device | Sciatic Nerve Catheter |
| Novel Internal Fixation Nerve Block Catheter - Saphenous nervePlacement of the saphenous catheter is contingent upon an amputation line that allows for placement below the surgical site (distal to the cut). | Device | Saphenous Nerve Catheter |
Primary outcome
Catheter Dislocation Distance
Time frame: From initial placement (Day 0) to immediately prior to amputation surgery (typically 48-72 hours).
The absolute distance (in millimeters) between the position of the catheter delivery orifice at initial placement and its position just before removal. The position is verified by ultrasound imaging using hydrodissection with a local anesthetic bolus to identify the orifice.
7 secondary outcomes
Time on Task
Time frame: At time of procedure (Day 0)
Primary Placement Success Rate
Time frame: At time of procedure (Day 0)
Catheter Clinical Performance (Sensory Block)
Time frame: Day 0 (preprocedure and postprocedure), day 1, day 2, and day 3.
Catheter Retraction Force
Time frame: Day 3 (just before surgery)
Pain Intensity (NRS)
Time frame: Day 0, Day 1, Day 2 and Day 3
Cumulative Opioid Consumption
Time frame: Day 0 to day 3 (Entire study duration)
Incidence of Adverse Events
Time frame: Day 0 to day 3 (Entire study duration)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- BackgroundCarvalho BY, Mariano ER. Continuous vs. single-injection peripheral nerve blocks: A prospective cohort study comparing procedural time and personnel cost. Open Anesthesiol J. 2015;9:1-5.
- Background: PubMed 30613945Martin N, Davis CJ. Evidence from masked-priming that initial identification of brand names is via abstract letter identities. Br J Psychol. 2019 Nov;110(4):745-768. doi: 10.1111/bjop.12362. Epub 2019 Jan 4.
- Background: PubMed 25727142Baillie J, Lankshear A. PATIENTS' AND RELATIVES' EXPERIENCES OF PERITONITIS WHEN USING PERITONEAL DIALYSIS. J Ren Care. 2015 Sep;41(3):177-86. doi: 10.1111/jorc.12118. Epub 2015 Feb 27.
- Background: PubMed 31785718Hauritz RW, Hannig KE, Balocco AL, Peeters G, Hadzic A, Borglum J, Bendtsen TF. Peripheral nerve catheters: A critical review of the efficacy. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):325-339. doi: 10.1016/j.bpa.2019.07.015. Epub 2019 Jul 22.
- Background: PubMed 27749354Ilfeld BM. Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and Comparison With Novel, Alternative Analgesic Modalities. Anesth Analg. 2017 Jan;124(1):308-335. doi: 10.1213/ANE.0000000000001581.
- Individual participant dataSharing planned: Undecided. Whether individual participant data will be shared has not yet been determined. The study evaluates novel design principles and mechanical fixation mechanisms for which intellectual property (IP) protection is currently being sought or finalized. A decision regarding the sharing of de-identified data will be made once the proprietary interests of the device design are fully secured and the primary feasibility analysis is complete.
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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.
Christoffer C Jørgensen, MD, PhD principal investigator
Nordsjaellands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve and Novel Internal Fixation Nerve Block Catheter - Saphenous nerve in people with Primary Condition: Nerve Block and Secondary Condition: Catheter Displacement, run by Nordsjaellands Hospital at 1 site in Denmark.
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 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: opening soon, as of the sponsor's last update on 4 Feb 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christoffer C Jørgensen, MD, PhD (+45 48296659, christoffer.calov.joergensen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheter Dislocation Distance (time frame: From initial placement (Day 0) to immediately prior to amputation surgery (typically 48-72 hours).). 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 NCT07385872, 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 4 Feb 2026.