- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06282341
Fatigue and Recovery: a Comparison Between Trail and Marathon (MARA-TRAIL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
France
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Saint-Etienne, France, France, 42055
- Unités de Myologie et de Médecine du Sport
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Common for MARASIM, TRAILSIM and TRAILNAT:
- Male or female
- 18-55 years old
- Endurance runners who run at least one running session of 20 km per week
- Being able to run a marathon under 5 h or finishing a trail of 30 km during the last 3 years
- Refrain from participating to a competition one month before the first visit and during the duration of the study
- To have a medical certificate of no contraindication of running practise in competition
- Registered with a social security scheme
- Having given the written consent freely
Specific for the 3 groups :
- Specialist of trail running (TRAILSIM and TRAILNAT)
- Specialist of road running (MARASIM)
Exclusion Criteria:
- Subjects who present cardiac or articular chronic pathologies (example: repeated sprain, patellar or joint problems)
- Subjects who present chronic or central neurological pathologies
- Subjects deprived of liberty or who should be legally deprived
- Subjects who report to take forbidden products by the World Anti-Doping Agency
- pregnant or breastfeeding woman
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: MARASIM
During visit 2, road runners will take part in a simulated marathon race on a treadmill.
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Participants will take part in a race: simulated marathon.
Before, during, immediately after and the month after the race, neuromuscular, physiological and biomechanical assessments will take place.
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Active Comparator: TRAILSIM
During visit 2, trail runners will take part in a simulated trail race on a treadmill.
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Participants will take part in a race: simulated trail.
Before, during, immediately after and the month after the race, neuromuscular, physiological and biomechanical assessments will take place.
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Active Comparator: TRAILNAT
During visit 2, trail runners will take part in a real trail race in the nature.
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Participants will take part in a race: trail in nature.
Before, during, immediately after and the month after the race, neuromuscular, physiological and biomechanical assessments will take place.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in knee extensors maximal isometric torque output
Time Frame: Day 0 (day of the race) baseline value = 30 minutes before the race and 15 minutes after the race
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The primary outcome will be changed (in % of baseline value) of the maximal voluntary torque (in Nm) produced by the knee extensors, measured at D0 (= day of the race) with an isometric knee dynamometer (ARS dynamometry, SP2, Ltd., Ljubljana, Slovenia), before (baseline value = 30 minutes before the race) and at the end (15 minutes after the race) of a marathon or a trail (depending on the group)
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Day 0 (day of the race) baseline value = 30 minutes before the race and 15 minutes after the race
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Resting heart rate variability parameters
Time Frame: 3 times in the 2 weeks before the race and every other day for the month following the race
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Evolution of resting heart rate variability, a marker of psychophysiological recovery will be assessed through a Polar H10 heart rate monitor before the race (at least 3 times in the 2 weeks before the race) and during recovery (at least every two days until one month after the race). Analysis of time domain and frequency domain variables via measurement of heart rate variability will be achieved through HRV analysis software. |
3 times in the 2 weeks before the race and every other day for the month following the race
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Change in plantar flexor maximal isometric torque output
Time Frame: Day 0 (day of the race) baseline value = 30 minutes before the race and 15 minutes after the race, Days 1, 2, 7
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Change (in % of baseline value) of the maximal voluntary torque (in Nm) produced by the plantar flexor measured at D0, by an instrumental pedal placed at 45 degrees with respect to the horizontal (ATI Industrial Automation, Inc., Apex, North Carolina USA), before (baseline value) and at the end of a marathon or a trail (depending on the group), and during recovery at Day1 Day2 Day7).
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Day 0 (day of the race) baseline value = 30 minutes before the race and 15 minutes after the race, Days 1, 2, 7
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Recovery of quadriceps maximal isometric torque output the month after the race
Time Frame: Day 0 (day of the race) baseline value = 30 minutes before the race, (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Change (in % of post-exercise baseline value) of the maximal voluntary torque (in Nm) produced by the knee extensors, measured with an isometric knee dynamometer (ARS dynamometry, SP2, Ltd., Ljubljana, Slovenia), during recovery at Day 1 Day 2 Day 7).
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Day 0 (day of the race) baseline value = 30 minutes before the race, (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Voluntary activation level
Time Frame: D0 (day of the race) baseline value = 30 min before the race, in the middle of the race (except for the trail in the nature) and 15 min after the race;D1 = 24h after the end of the race , D2 = 48h after the end of the race, D7 = 7 days after the end
|
Voluntary activation level (in %) of the plantar flexors and knee extensors will be assessed through neuromuscular assessments before, in the middle (except for the trail in the nature), after the marathon or trail of equivalent effort, and during recovery (Day 1, Day 2, and Day 7). Voluntary activation level will be calculated as followed: VA (%) = (1- (superimposed Db100/ resting Db100))x100 |
D0 (day of the race) baseline value = 30 min before the race, in the middle of the race (except for the trail in the nature) and 15 min after the race;D1 = 24h after the end of the race , D2 = 48h after the end of the race, D7 = 7 days after the end
|
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Force assessed in dynamic
Time Frame: Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Force assessed in dynamic mode on a cycloergometer (Monark, Vansbro, Sweden) composed of strain gauges, a flywheel, a belt and an optical encoder allowing data collection.
Force (N) will be measured in order to establish a force-velocity / power- velocity profile at Day 0 15 min before the race, after the marathon or trail ( 1 hour after the end) of equivalent effort, and during recovery (Day 1 (= 24h after the end of the race) , Day 2 (= 48 h after the end of the race), Day 7 (= 7 days after the end of the race).
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Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Velocity assessed in dynamic
Time Frame: Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Velocity assessed in dynamic mode on a cycloergometer (Monark, Vansbro, Sweden) composed of strain gauges, a flywheel, a belt and an optical encoder allowing data collection.
Speed (rad/s) will be measured in order to establish a force-velocity / power-velocity profile before (=15 minutes before the race), after the marathon or trail (=1 hour after the end) of equivalent effort, and during recovery (Day 1 = 24hours after the end of the race, Day 2 = 48hours after the end of the race, Day 7 = 7 days after the end of the race).
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Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Power assessed in dynamic
Time Frame: Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Power assessed in dynamic mode on a cycloergometer (Monark, Vansbro, Sweden) composed of strain gauges, a flywheel, a belt and an optical encoder allowing data collection.
Power (W) will be measured in order to establish a force-velocity / power-velocity profile before (=15 minutes before the race), after the marathon or trail (=1 hour after the end) of equivalent effort, and during recovery (Day 1 = 24hours after the enf of the race, Day 2 = 45hours after the end of the race, Day 7= 7 days after the race).
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Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Muscular power and stretch-shortening cycle assessed through squat jumps
Time Frame: Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Muscular power and stretch-shortening cycle assessed through squat jump ; Height (m) and duration (s) of jumps are calculated through force platform (90 x90 cm, Model 9287C, Kisler, Winterthur, Switzerland).
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Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Muscular power and stretch-shortening cycle assessed through countermovement jump
Time Frame: Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Muscular power and stretch-shortening cycle assessed through countermovement.
Height (meter) and duration (seconde) of jumps are calculated through force platform (90 x90 centimeter, Model 9287C, Kisler, Winterthur, Switzerland)
|
Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Muscular power and stretch-shortening cycle assessed through drop jump
Time Frame: Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Muscular power and stretch-shortening cycle assessed through drop jump.
Height (m) and duration (s) of jumps are calculated through force platform (90 x90 cm, Model 9287C, Kisler, Winterthur, Switzerland)
|
Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Muscle electrical activity
Time Frame: Day 0: 30 minutes before the race, in the middle (except for the trail in the nature) 15 minutes after the end of the race
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Muscle electrical activity (Trigno avanti Sensor, Delsys, Natick, MA including electrodes connected to thin-10-cm-long cables) are measured
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Day 0: 30 minutes before the race, in the middle (except for the trail in the nature) 15 minutes after the end of the race
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The kinetics of energy cost
Time Frame: Day 0 1 hour 30 minutes before the race,in the middle, 30 minutes after the end of the race, and during recovery (Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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The kinetics of energy cost (Ccr en J/kg/m) measured using a portable gas exchange measurement system (Ergospirometer Metamax 3B®, Cortex Medical, Leipzig, Germany) 1h30 before the race, in the middle (except for the trail in the nature) and 30 min after the race the marathon or simulated trail and during recovery Day 1, Day 2, Day 7 7)7).measurement
system (Ergospirometer Metamax 3B®, Cortex Medical, Leipzig, Germany)
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Day 0 1 hour 30 minutes before the race,in the middle, 30 minutes after the end of the race, and during recovery (Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Racing kinematics
Time Frame: 1 hour before, in the middle and immediately after the race and during recovery(Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Evolution of moments and hip joint angles, knee and ankle measured by a Markerless tracking system will be measured 1 hour before the race , in the middle (except for the trail in the nature), immediately after the simulated trail or marathon, and during recovery (Day 1 (= 24hours after the end of the race) , Day 2 (= 48hours after the end of the race), Day 7 (= 7 days after the end of the race). |
1 hour before, in the middle and immediately after the race and during recovery(Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Ground reaction force (in Newton)
Time Frame: 1hour before, in the middle (except for the trail in the nature) and immediately after the race and during recovery(Day 1 (= 24hours after the end of the race) , Day 2 (= 48hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Force will be measured by force platforms contained in the treadmill (h/p/Cosmos-Stellar, Germany).
to get the ground reaction forces at each step 1hour before, in the middle (except for the trail in the nature) and immediately after the race and during recovery(Day 1 (= 24hours after the end of the race) , Day 2 (= 48hours after the end of the race), Day 7 (= 7 days after the end of the race).
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1hour before, in the middle (except for the trail in the nature) and immediately after the race and during recovery(Day 1 (= 24hours after the end of the race) , Day 2 (= 48hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Center of pressure (in Newton)
Time Frame: 1hour before, in the middle (except for the trail in the nature) and immediately after the race and during recovery(Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
|
Force will be measured by force platforms contained in the treadmill (h/p/Cosmos-Stellar, Germany).
to get the center of pressure each step before (=1 hour before), in the middle (except for the trail in the nature), after (=immediately after the race) the simulated trail or marathon, and during recovery (Day 1 = 24 hours after the race, Day 2 = 48 hours after the race, Day 7 = 7 days after the race)
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1hour before, in the middle (except for the trail in the nature) and immediately after the race and during recovery(Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Muscle damage blood markers
Time Frame: Day 0: 2hours before the race, 2hours after the race and during recovery (Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Witness muscle damage following a marathon or a trail of equivalent effort.
Biological variables are taken 2h before the race and 2 h after the race: a marathon or a trail of equivalent effort, and during recovery ((Day 1 (= 24h after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Followed i- Inflammatory parameters are taken through blood test (2 tubes of 5 ml/blood test): ionogram (sodium [mmol/l], potassium [mmol/l], chlorine [mmol/l], bicarbonates [mmol/l], urea [mmol/l], creatinine [µmol/l], glucose [mmol/l], proteins [g/l], uric acid [[µmol/l ], osmolality [m0smol/kg]; Creatine Kinase (UI/l)myoglobine [µg/l ], C reactive Protein [mg/l], lactate [mmol/l]
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Day 0: 2hours before the race, 2hours after the race and during recovery (Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
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Effort perception
Time Frame: D0 (day of the race) : during the race, every 5 kilometers effort
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Perception of effort will be assessed during the marathon or trail of equivalent effort every 5 km effort on the modified Borg scale (from 0 - rest to 10 - Maximal perceived effort).
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D0 (day of the race) : during the race, every 5 kilometers effort
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Fatigue assessment
Time Frame: Once during 2 weeks before, immediately after the race and during recovery (Day 1 = 24 hours after the race, Day 2 = 48 hours after, Day 3 = 72 hours after, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21 and Day 30 after the race
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Fatigue assessment will be carried out before (=once during the 2 weeks before the race) the marathon or trail of equivalent effort , immediately after and during recovery (Day 1 = 24 hours after the race, Day 2 = 48 hours after the race, Day 3 = 72 hours after the race, Day 4 = 4 days after the race, Day 5 = 5 days after the race, Day 6 = 6 days after the race, Day 7 = 7 days after the race, Day 14 = 14 days after the race, Day 21 = 21 days after the race, Day 30 = 30 days after the race) via the of the "Rating scale of fatigue " (from 0 - Not fatigued at all to 10 - Total exhaustion nothing left).
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Once during 2 weeks before, immediately after the race and during recovery (Day 1 = 24 hours after the race, Day 2 = 48 hours after, Day 3 = 72 hours after, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21 and Day 30 after the race
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Muscular pain
Time Frame: Day 0 (day of the race) : during the race, every 5 kilometers effort
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Muscle pain felt in the quadriceps and calves will be rated on a visual analog scale ranging from 0 (No muscular pain at all) at 10 (Unbearable muscle pain) during the marathon or trail of equivalent effort every 5 km-effort
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Day 0 (day of the race) : during the race, every 5 kilometers effort
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Collaborators and Investigators
Investigators
- Principal Investigator: Leonard FEASSON, MD PhD, CHU Saint-Etienne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23CH132
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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