PainTRANSITNCT04312685
Transitioning to a Valve -Gated Intrathecal Drug Delivery System
A study testing Prometra II Programmable Pump system - Flowonix Medical in people with Pain and Pain, Chronic, run by Bux, Anjum, MD at 8 sites in United States.
Trial summary
This study is designed to explore if the valve-gated pump requires less drug to manage subject pain than the prior standard peristaltic pump in the same subject. The newly implanted valve-gated pump will be programmed to deliver a minimum dose reduction of 20% of the same medication that was delivered in the… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Pain, Chronic, Pain, Intractable
- What is being tested?
- Prometra II Programmable Pump system - Flowonix Medical
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 8 sitesUnited States
- Study dates
- 27 Jul 2020to 30 Nov 2023
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects meeting all of the following criteria will be eligible for enrollment in the study:
- 21 years of age or older
- Provide written informed consent for study participation
- Active existing peristaltic intrathecal drug delivery system (IDDS)
- Stable IDDS dosage and concentration for at least 6 weeks prior to valve-gated pump implant
- Minimum of 3 months of information from the following:
Show all 14Show fewer
- VAS, ODI, Global Pain Scale
- Pump refill printouts (dosage and concentration)
- Other Interventions for pain (injections, nerve blocks, etc.)
- Estimated Replacement Indicator (ERI) printout required showing < 12 months of battery life
- Catheter Access Procedure (CAP) study performed to document patency of catheter, if not replacing
- Diagnosis of nonmalignant, chronic intractable pain as documented in medical history
- Appropriate candidate for surgery
- Able to comply with study requirements including visits and assessments, in the opinion of the investigator
Who cannot join
- Subjects meeting any of the following criteria will be excluded from participating in the study:
- Any contraindications listed in the Prometra labeling
- Significant pain disorder not intended to be treated with the test device or comparator
- Terminally ill, malignant cancer diagnosis and/or has a life expectancy of less than 12 months in the opinion of the investigator
- Pregnant/lactating woman or is of child-bearing potential and not utilizing effective birth control.
- Systemic or local infection (contraindicated for pump implantation)
- History/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments, in the investigator's opinion
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Consultants in Pain Management
Chattanooga, Tennessee, 37421
Pain and Spine Specialists
Idaho Falls, Idaho, 83404
Bux Pain Management
Lexington, Kentucky, 40509
Crimson Pain Management
Overland Park, Kansas, 66209
The Spine Center at Ridgeway
Rochester, New York, 14626
Aust Interventional Pain
Slidell, Louisiana, 70458
Michigan Head & Spine Institute
Southfield, Michigan, 48034
National Spine & Pain Center
Turnersville, New Jersey, 08012
About this study
Official title: Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center Study
This study is designed to explore if the valve-gated pump requires less drug to manage subject pain than the prior standard peristaltic pump in the same subject. The newly implanted valve-gated pump will be programmed to deliver a minimum dose reduction of 20% of the same medication that was delivered in the peristaltic pump prior to explant. The drug therapy will be evaluated and pain scores will be evaluated over time (3 refill cycles prospectively for the valve-gated pump and 6 months retrospectively for the peristaltic pump).
Read the detailed description
This study will employ a single-blind where study participants will not be told about the dose reduction of at least 20% when the valve-gated pump is implanted. A study participant has a significant potential to bias when informed they will get less drug with the new pump than they were receiving in the old pump this could subjectively affect pain scores as well. After valve-gated pump implant and dose reduction, the appropriate pain therapy will be provided to adequately address pain management in the opinion of the study investigator using standard of care processes and VAS scores.
Once subjects have been implanted with the valve-gated pump they will be started on a minimum 20% dose reduction (same medications and concentrations prior to explant). If at any time during the subjects' treatment it is determined by the investigator that the subjects' treatment dose needs to be increased, the dose can be increased in increments not to exceed 5% (no change to concentration) based on VAS scores at current and last visits.
- Conditions
- Pain, Pain, Chronic, Pain, Intractable, Pain, Back
- Being tested
- Prometra II Programmable Pump system - Flowonix Medical
- Keywords
- IDDS, Intrathecal drug therapy, pain pump
- Medical subject headings
- Pain, Chronic Pain, Pain, Intractable, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prometra II Programmable Pump system - Flowonix MedicalDevice
Also called Prior peristaltic Synchromed II pump
This valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump
| Study group | Role | What they receive |
|---|---|---|
| Prometra Programmable Pump | Active comparator | Pain scores and drug doses will be prospectively collected for valve-gated Prometra® Programmable Pump system(Flowonix Medical)' at (refills 1-3) and will be compared to 3 months retrospectively collected pain scores (VAS, ODI and Global Pain Scale Assessments) and drug doses prior to peristaltic pump explant. Receives: Device: Prometra II Programmable Pump system - Flowonix Medical |
| Retrospective records for peristaltic pump | No intervention | Prior pain scores and drug doses from the patients who need a new valve gated pump will be recorded and used for comparison after it is changed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced pain medication through Prometra Implantable Pump System
Total consumption of pain medications both oral and intrathecal is recorded to show changes.
Measured: 12 months
Secondary outcomes (3)
Visual Analog Scale for Pain changes
Visual Analog Scale (VAS) for Pain is used assess pain throughout the study which shows No pain at low end to extreme Pain at high end.
Measured: 12 months
Owestry Disability Index changes
Owestry Disability Index (ODI) are used to assess changes in lifestyle scores throughout the study which shows patient's level of function in daily living
Measured: 12 months
Global Pain Scale Assessments
Global Pain Scale Assessments will be used to assess changes in scores throughout the study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start27 Jul 2020
- Primary completion1 Apr 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-Label, Non-Randomized, Single-Blind, Multi-Center
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bux, Anjum, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Flowonix Medical
- Responsible party
- Sponsor
- Investigators
- Anjum Bux, MD, Principal investigator, Owner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312685
- Sponsor's protocol ID
- T-001
- Acronym
- TRANSIT
- Status last verified
- Jul 2021
- First submitted
- 16 Mar 2020
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Knight KH, Brand FM, Mchaourab AS, Veneziano G. Implantable intrathecal pumps for chronic pain: highlights and updates. Croat Med J. 2007 Feb;48(1):22-34.
PubMed 17309136Deer TR, Smith HS, Cousins M, Doleys DM, Levy RM, Rathmell JP, Staats PS, Wallace M, Webster LR. Consensus guidelines for the selection and implantation of patients with noncancer pain for intrathecal drug delivery. Pain Physician. 2010 May-Jun;13(3):E175-213.
PubMed 20495597Hayek SM, Deer TR, Pope JE, Panchal SJ, Patel VB. Intrathecal therapy for cancer and non-cancer pain. Pain Physician. 2011 May-Jun;14(3):219-48.
PubMed 21587327Hayek SM, Veizi E, Hanes M. Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device. Pain Med. 2016 Mar;17(3):561-571. doi: 10.1093/pm/pnv021. Epub 2015 Dec 14.
PubMed 26814257Konrad PE, Huffman JM, Stearns LM, Plunkett RJ, Grigsby EJ, Stromberg EK, Roediger MP, Wells MD, Weaver TW. Intrathecal Drug Delivery Systems (IDDS): The Implantable Systems Performance Registry (ISPR). Neuromodulation. 2016 Dec;19(8):848-856. doi: 10.1111/ner.12524. Epub 2016 Oct 12.
PubMed 27730704Tangen KM, Leval R, Mehta AI, Linninger AA. Computational and In Vitro Experimental Investigation of Intrathecal Drug Distribution: Parametric Study of the Effect of Injection Volume, Cerebrospinal Fluid Pulsatility, and Drug Uptake. Anesth Analg. 2017 May;124(5):1686-1696. doi: 10.1213/ANE.0000000000002011.
PubMed 28431428
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center Study
- ClinicalTrials.gov ID
- NCT04312685
- Acronym / sponsor ID
- TRANSIT / T-001
- Conditions
- Pain, Pain, Chronic, Pain, Intractable, Pain, Back
- Keywords
- IDDS, Intrathecal drug therapy, pain pump
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bux, Anjum, MDUniversity, hospital or other
- Collaborators
- Flowonix Medical
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 18 Mar 2020 (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 is designed to explore if the valve-gated pump requires less drug to manage subject pain than the prior standard peristaltic pump in the same subject. The newly implanted valve-gated pump will be programmed to deliver a minimum dose reduction of 20% of the same medication that was delivered in the peristaltic pump prior to explant. The drug therapy will be evaluated and pain scores will be evaluated over time (3 refill cycles prospectively for the valve-gated pump and 6 months retrospectively for the peristaltic pump).
Detailed description
This study will employ a single-blind where study participants will not be told about the dose reduction of at least 20% when the valve-gated pump is implanted. A study participant has a significant potential to bias when informed they will get less drug with the new pump than they were receiving in the old pump this could subjectively affect pain scores as well. After valve-gated pump implant and dose reduction, the appropriate pain therapy will be provided to adequately address pain management in the opinion of the study investigator using standard of care processes and VAS scores.
Once subjects have been implanted with the valve-gated pump they will be started on a minimum 20% dose reduction (same medications and concentrations prior to explant). If at any time during the subjects' treatment it is determined by the investigator that the subjects' treatment dose needs to be increased, the dose can be increased in increments not to exceed 5% (no change to concentration) based on VAS scores at current and last visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Open-Label, Non-Randomized, Single-Blind, Multi-Center
| Arm | Type | Receives |
|---|---|---|
| Prometra Programmable Pump | Active comparator | Device: Prometra II Programmable Pump system - Flowonix MedicalPain scores and drug doses will be prospectively collected for valve-gated Prometra® Programmable Pump system(Flowonix Medical)' at (refills 1-3) and will be compared to 3 months retrospectively collected pain scores (VAS, ODI and Global Pain Scale Assessments) and drug doses prior to peristaltic pump explant. |
| Retrospective records for peristaltic pump | No intervention | –Prior pain scores and drug doses from the patients who need a new valve gated pump will be recorded and used for comparison after it is changed. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects meeting all of the following criteria will be eligible for enrollment in the study:
- 21 years of age or older
- Provide written informed consent for study participation
- Active existing peristaltic intrathecal drug delivery system (IDDS)
- Stable IDDS dosage and concentration for at least 6 weeks prior to valve-gated pump implant
Key exclusion criteria (7 listed)
- Subjects meeting any of the following criteria will be excluded from participating in the study:
- Any contraindications listed in the Prometra labeling
- Significant pain disorder not intended to be treated with the test device or comparator
- Terminally ill, malignant cancer diagnosis and/or has a life expectancy of less than 12 months in the opinion of the investigator
- Pregnant/lactating woman or is of child-bearing potential and not utilizing effective birth control.
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 |
|---|---|---|
| Prometra II Programmable Pump system - Flowonix MedicalAlso: Prior peristaltic Synchromed II pumpThis valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump | Device | Prometra Programmable Pump |
Primary outcome
Reduced pain medication through Prometra Implantable Pump System
Time frame: 12 months
Total consumption of pain medications both oral and intrathecal is recorded to show changes.
3 secondary outcomes
Visual Analog Scale for Pain changes
Time frame: 12 months
Owestry Disability Index changes
Time frame: 12 months
Global Pain Scale Assessments
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Background: PubMed 17309136Knight KH, Brand FM, Mchaourab AS, Veneziano G. Implantable intrathecal pumps for chronic pain: highlights and updates. Croat Med J. 2007 Feb;48(1):22-34.
- Background: PubMed 20495597Deer TR, Smith HS, Cousins M, Doleys DM, Levy RM, Rathmell JP, Staats PS, Wallace M, Webster LR. Consensus guidelines for the selection and implantation of patients with noncancer pain for intrathecal drug delivery. Pain Physician. 2010 May-Jun;13(3):E175-213.
- Background: PubMed 21587327Hayek SM, Deer TR, Pope JE, Panchal SJ, Patel VB. Intrathecal therapy for cancer and non-cancer pain. Pain Physician. 2011 May-Jun;14(3):219-48.
- Background: PubMed 26814257Hayek SM, Veizi E, Hanes M. Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device. Pain Med. 2016 Mar;17(3):561-571. doi: 10.1093/pm/pnv021. Epub 2015 Dec 14.
- Background: PubMed 27730704Konrad PE, Huffman JM, Stearns LM, Plunkett RJ, Grigsby EJ, Stromberg EK, Roediger MP, Wells MD, Weaver TW. Intrathecal Drug Delivery Systems (IDDS): The Implantable Systems Performance Registry (ISPR). Neuromodulation. 2016 Dec;19(8):848-856. doi: 10.1111/ner.12524. Epub 2016 Oct 12.
- Background: PubMed 28431428Tangen KM, Leval R, Mehta AI, Linninger AA. Computational and In Vitro Experimental Investigation of Intrathecal Drug Distribution: Parametric Study of the Effect of Injection Volume, Cerebrospinal Fluid Pulsatility, and Drug Uptake. Anesth Analg. 2017 May;124(5):1686-1696. doi: 10.1213/ANE.0000000000002011.
- Individual participant dataSharing planned: No
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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.
Anjum Bux, MD principal investigator
Owner
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prometra II Programmable Pump system - Flowonix Medical in people with Pain and Pain, Chronic, run by Bux, Anjum, MD 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 14 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Jul 2021. 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?
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?
Reduced pain medication through Prometra Implantable Pump System (time frame: 12 months). 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 NCT04312685, which also lists 6 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 7 Jul 2021.