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| Name | Class |
|---|---|
| Gate Science | INDUSTRY |
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Postoperative pain remains undertreated with inadequate analgesic options. Opioids have well-known limitations for both individuals and society; single-injection and continuous peripheral nerve blocks provide intense analgesia but are limited in duration to 24-72 hours; and current neuromodulation options-with a duration measured in weeks and not hours-are prohibitively expensive and require an additional procedure. One possible solution is a device currently under investigation to treat postoperative pain. The RELAY system (Gate Science, Moultonborough, New Hampshire) is comprised of a basic catheter-over-needle device to allow administration of a single-injection of local anesthetic via the needle (or catheter) followed by a perineural local anesthetic infusion via the remaining catheter (when desired). Subsequent to the local anesthetic administration, instead of removing the catheter as with all previous continuous peripheral nerve block equipment, electric current may be delivered via the same catheter and an integrated pulse generator for up to 28 days. This is potentially revolutionary because it would allow an anesthesiologist to deliver (1) a single-injection peripheral nerve block; (2) a continuous peripheral nerve block; and (3) neuromodulation using a single device that can theoretically be placed in the same amount of time required for a single-injection peripheral nerve block. Instead of providing fewer than 24 hours of postoperative analgesia, up to 28 days of pain control could be delivered without disruption of existing practice patterns. The ultimate objective of the proposed investigation is to prepare for a randomized clinical trial investigating the use of the RELAY device to provide postoperative analgesia.
This feasibility study will be a series of participants all receiving both local anesthetic and electric current via a single device (RELAY, Gate Science, Moultonborough, New Hampshire). The purpose will be to optimize the insertion approach and stimulation administration during the first 7 days following foot and shoulder surgery as well as training the clinical investigators.
Specific Aim: To determine the feasibility and optimize the protocol for the RELAY device following foot and shoulder surgery to prepare for the subsequent randomized, controlled pilot study.
For individuals of childbearing potential, a sample of urine will be collected before any study interventions to confirm a non-pregnant state (this is standard procedure for all surgical patients). The RELAY device combines a catheter-over-needle to permit ultrasound-guided percutaneous insertion with the tip adjacent to a peripheral nerve or plexus, followed by needle removal which leaves the catheter in situ to deliver a bolus of local anesthetic (if desired) and subsequent perineural local anesthetic infusion (if desired). The catheter also has 3 integrated electrodes to enable neuromodulation using the integrated pulse generator and battery.
Participants will have standard external monitors placed and oxygen delivered by facemask or nasal cannula. The peripheral nerve block site(s) will be cleansed with chlorhexidine gluconate and isopropyl alcohol. Intravenous sedation/analgesia with midazolam and/or fentanyl will be titrated for patient comfort as is standard for peripheral nerve block administration. The nerves treated will include the sciatic proximal to the popliteal crease for foot surgery and the brachial plexus for shoulder surgery. The target nerve(s) will be visualized with ultrasound using a transverse cross-sectional (short axis) view and a skin wheal of local anesthetic will be raised inferior to the transducer to anesthetize the skin and then the track towards the target. The RELAY with the integrated needle will be inserted adjacent to the target nerve with an in-plane approach. Dextrose 5% in water (1-20 mL) will be injected via the needle to open a space around the target nerve(s), the catheter advanced, and the needle subsequently withdrawn.
Electrical current will be introduced with increasing intensity via each of the anode electrodes to optimize participant's perceived stimulation (control provided by the Gate Keeper app from an investigator's phone or tablet). Accurate lead placement will be confirmed with subject reports of comfortable sensations over the surgical site without eliciting muscle contractions. The minimum threshold and maximum comfortable amplitudes will be determined along with the optimal frequency, pulse duration, and anode/cathode. Starting from the lowest possible current the investigators increase the current until the participant states that they feel a "buzzing" sensation (some describe it as a "comfortable massage"). That is the minimal sensed current. The investigators then continue increasing with the instructions to let us know when it starts to be less comfortable-and to stop us before it hurts. That is the maximum comfortable current. The stimulator will be then set to deliver the minimum threshold amplitude and turned off for surgery. The pulse generator of the RELAY has a frequency between 1-250 Hz, a pulse duration of 1-200 µs, and a current of 0.001-10 mA (1-10,000 µA). The investigators will maximize frequency, minimize pulse duration, and have participants adjust the amplitude following surgery, as needed.
Local anesthetic (10 mL of lidocaine 2% with epinephrine) will be injected with negative aspiration every 3 mL and resulting sensory block confirmed to ensure accurate catheter tip placement. Following block confirmation (sensory deficits in the expected nerve distributions), the RELAY will be affixed with both surgical adhesive (2-Octyl 2-cyanoacrylate) at the entry site and a chlorohexidine-impregnated occlusive dressing [research specific]. Subsequently, 10 mL of bupivacaine 0.5% with epinephrine will be injected negative aspiration every 3 mL along with a supplemental single-injection saphenous nerve block for foot/ankle surgery.
Intraoperatively, surgeons will be permitted to infiltrate the surgical area with long-acting local anesthetic as their common practice dictates.
Postoperatively, the stimulators will be connected to participants' phones and turned on. If a patient's surgeon requests a postoperative continuous peripheral nerve block, a ropivacaine 0.2% infusion will be provided per standard UC San Diego protocol. After 7 days, participants themselves or their caretaker will remove the occlusive dressing and withdraw the catheter (and integrated electrodes) with gentle traction and rotation at home. The devices are single-use and disposable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Treatment | Experimental | RELAY catheter will be inserted under ultrasound guidance followed by a local anesthetic bolus injection. If a patient's surgeon requests a postoperative continuous peripheral nerve block, a ropivacaine 0.2% infusion will be initiated in the recovery room. Within the recovery room, the stimulators will be connected to participants' phones and turned on. The catheters will be removed on postoperative day 7. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Treatment | Device | Percutaneous peripheral nerve stimulation with a frequency between 1-250 Hz, a pulse duration of 1-200 µs, and a current of 0.001-10 mA (1-10,000 µA). If the same pattern holds for the RELAY device as for previously tested peripheral nerve stimulators, we will maximize frequency, minimize pulse duration, and have participants adjust the amplitude, as needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Pain Intensity 1st Week | The median of 5 daily "average" pain intensity scores for Days 1-4 and 7 as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst) | Days 1-4 and 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Opioid Use 1st Week | The cumulative opioid use measured in oxycodone equivalents during the first 7 days following surgery | The first 7 days following surgery |
| Brief Pain Inventory (Interference Sub Scale) Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian M Ilfeld, MD, Ms | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41005804 | Result | Ilfeld BM, Said ET, Park BH, Sinha SK, Leek B, Meunier MJ, Foran IM, Hurvitz A, Kent WT, Schwartz AK, Abdullah B, Alkabalan R, Lau N, Finneran JJ. Percutaneous analgesic device enabling both local anesthetic delivery and electrical stimulation (neuromodulation) of peripheral nerves: a pilot feasibility study (case series). Reg Anesth Pain Med. 2026 May 5;51(5):498-503. doi: 10.1136/rapm-2025-107029. |
| Label | URL |
|---|---|
| article containing the results | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Treatment | RELAY catheter will be inserted under ultrasound guidance followed by a local anesthetic bolus injection. If a patient's surgeon requests a postoperative continuous peripheral nerve block, a ropivacaine 0.2% infusion will be initiated in the recovery room. Within the recovery room, the stimulators will be connected to participants' phones and turned on. The catheters will be removed on postoperative day 7. Experimental Treatment: Percutaneous peripheral nerve stimulation with a frequency between 1-250 Hz, a pulse duration of 1-200 µs, and a current of 0.001-10 mA (1-10,000 µA). If the same pattern holds for the RELAY device as for previously tested peripheral nerve stimulators, we will maximize frequency, minimize pulse duration, and have participants adjust the amplitude, as needed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2025 |
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A series of participants all receiving active treatment
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The Brief pain Inventory (short form) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning. The brief Inventory is comprised of three domains: (1) pain, with four questions involving "worst", "average" and "current" pain levels using a 0-10 numeric rating scale; (2) percentage of relief provided by pain treatments with one question [reported score is the percentage divided by 10 and then subtracted from 10: 0=complete relief,10=no relief] and, (3) interference with 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0=no interference;10=complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. This outcome will include solely the interference subscale with a minimum score of 0 (optimal outcome) and maximum score of 70 (worst possible outcome).
| Postoperative day 3 |
| Brief Pain Inventory (Interference Sub Scale) Day 7 | The Brief pain Inventory (short form) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning. The brief Inventory is comprised of three domains: (1) pain, with four questions involving "worst", "average" and "current" pain levels using a 0-10 numeric rating scale; (2) percentage of relief provided by pain treatments with one question [reported score is the percentage divided by 10 and then subtracted from 10: 0=complete relief,10=no relief] and, (3) interference with 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0=no interference;10=complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. This outcome will include solely the interference subscale with a minimum score of 0 (optimal outcome) and maximum score of 70 (worst possible outcome). | Postoperative day 7 |
| Worst Daily Pain Intensity 1st Week | The median of 5 daily "worst" (maximum) pain intensity scores for Days 1-4 and 7 as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst) | Days 1-4 and 7 |
| Awakenings Due to Pain 1st Week | Cumulative number of nightly awakenings due to pain | Collected on postoperative days 1, 2, 3, 4, and 7 |
| Average Daily Pain Intensity Day 7 | The "average" pain intensity score on Day 7 as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst) | Day 7 |
| Worst (Maximum) Daily Pain Intensity Day 7 | The "worst" pain intensity score on Day 7 as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst) | Day 7 |
| Opioid Consumption Day 7 | The cumulative opioid use from the previous 24 hours measured in oxycodone equivalents as recorded on Day 7 | Day 7 |
| Daily "Average" Pain Intensity | The "average" pain intensity score on each postoperative day as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst) | postoperative Days 1, 2, 3, 4, 7, 8 and 14 |
| Daily "Worst" Pain Intensity | The "worst" pain intensity score on each postoperative day as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst) | postoperative Days 1, 2, 3, 4, 7, 8 and 14 |
| Daily Opioid Consumption | The cumulative opioid use from the previous 24 hours measured in oxycodone equivalents as recorded on Days 1-4, 7, 8, and 14 | postoperative Days 1, 2, 3, 4, 7, 8 and 14 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Treatment | RELAY catheter will be inserted under ultrasound guidance followed by a local anesthetic bolus injection. If a patient's surgeon requests a postoperative continuous peripheral nerve block, a ropivacaine 0.2% infusion will be initiated in the recovery room. Within the recovery room, the stimulators will be connected to participants' phones and turned on. The catheters will be removed on postoperative day 7. Experimental Treatment: Percutaneous peripheral nerve stimulation with a frequency between 1-250 Hz, a pulse duration of 1-200 µs, and a current of 0.001-10 mA (1-10,000 µA). If the same pattern holds for the RELAY device as for previously tested peripheral nerve stimulators, we will maximize frequency, minimize pulse duration, and have participants adjust the amplitude, as needed. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight (kg) | Mean | Standard Deviation | kg |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Daily Pain Intensity 1st Week | The median of 5 daily "average" pain intensity scores for Days 1-4 and 7 as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst) | Posted | Median | Inter-Quartile Range | units on a scale | Days 1-4 and 7 |
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| Secondary | Cumulative Opioid Use 1st Week | The cumulative opioid use measured in oxycodone equivalents during the first 7 days following surgery | Posted | Median | Inter-Quartile Range | milligrams | The first 7 days following surgery |
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| Secondary | Brief Pain Inventory (Interference Sub Scale) Day 3 | The Brief pain Inventory (short form) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning. The brief Inventory is comprised of three domains: (1) pain, with four questions involving "worst", "average" and "current" pain levels using a 0-10 numeric rating scale; (2) percentage of relief provided by pain treatments with one question [reported score is the percentage divided by 10 and then subtracted from 10: 0=complete relief,10=no relief] and, (3) interference with 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0=no interference;10=complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. This outcome will include solely the interference subscale with a minimum score of 0 (optimal outcome) and maximum score of 70 (worst possible outcome). | Posted | Median | Inter-Quartile Range | units on a scale | Postoperative day 3 |
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| Secondary | Brief Pain Inventory (Interference Sub Scale) Day 7 | The Brief pain Inventory (short form) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning. The brief Inventory is comprised of three domains: (1) pain, with four questions involving "worst", "average" and "current" pain levels using a 0-10 numeric rating scale; (2) percentage of relief provided by pain treatments with one question [reported score is the percentage divided by 10 and then subtracted from 10: 0=complete relief,10=no relief] and, (3) interference with 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0=no interference;10=complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. This outcome will include solely the interference subscale with a minimum score of 0 (optimal outcome) and maximum score of 70 (worst possible outcome). | Posted | Median | Inter-Quartile Range | units on a scale | Postoperative day 7 |
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| Secondary | Worst Daily Pain Intensity 1st Week | The median of 5 daily "worst" (maximum) pain intensity scores for Days 1-4 and 7 as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst) | Posted | Median | Inter-Quartile Range | units on a scale | Days 1-4 and 7 |
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| Secondary | Awakenings Due to Pain 1st Week | Cumulative number of nightly awakenings due to pain | Posted | Median | Inter-Quartile Range | number of awakenings | Collected on postoperative days 1, 2, 3, 4, and 7 |
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| Secondary | Average Daily Pain Intensity Day 7 | The "average" pain intensity score on Day 7 as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst) | Posted | Median | Inter-Quartile Range | units on a scale | Day 7 |
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| Secondary | Worst (Maximum) Daily Pain Intensity Day 7 | The "worst" pain intensity score on Day 7 as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst) | Posted | Median | Inter-Quartile Range | units on a scale | Day 7 |
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| Secondary | Opioid Consumption Day 7 | The cumulative opioid use from the previous 24 hours measured in oxycodone equivalents as recorded on Day 7 | Posted | Median | Inter-Quartile Range | milligrams | Day 7 |
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| Secondary | Daily "Average" Pain Intensity | The "average" pain intensity score on each postoperative day as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst) | Posted | Median | Inter-Quartile Range | units on a scale | postoperative Days 1, 2, 3, 4, 7, 8 and 14 |
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| Secondary | Daily "Worst" Pain Intensity | The "worst" pain intensity score on each postoperative day as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst) | Posted | Median | Inter-Quartile Range | units on a scale | postoperative Days 1, 2, 3, 4, 7, 8 and 14 |
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| Secondary | Daily Opioid Consumption | The cumulative opioid use from the previous 24 hours measured in oxycodone equivalents as recorded on Days 1-4, 7, 8, and 14 | Posted | Median | Inter-Quartile Range | milligrams | postoperative Days 1, 2, 3, 4, 7, 8 and 14 |
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14 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Experimental Treatment | RELAY catheter will be inserted under ultrasound guidance followed by a local anesthetic bolus injection. If a patient's surgeon requests a postoperative continuous peripheral nerve block, a ropivacaine 0.2% infusion will be initiated in the recovery room. Within the recovery room, the stimulators will be connected to participants' phones and turned on. The catheters will be removed on postoperative day 7. Experimental Treatment: Percutaneous peripheral nerve stimulation with a frequency between 1-250 Hz, a pulse duration of 1-200 µs, and a current of 0.001-10 mA (1-10,000 µA). If the same pattern holds for the RELAY device as for previously tested peripheral nerve stimulators, we will maximize frequency, minimize pulse duration, and have participants adjust the amplitude, as needed. | 0 | 20 | 0 | 20 | 5 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Baton separation from pulse generator during intentional removal | Surgical and medical procedures | Non-systematic Assessment |
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| Perineural catheter occlusion | Surgical and medical procedures | Non-systematic Assessment |
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| Accidental catheter dislodgment | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Baharin Abdullah | University of California San Diego | +1 858-220-5714 | baabdullah@health.ucsd.edu |
| Oct 19, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D006215 | Hallux Valgus |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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