Edema LegNCT05312060
Pneumatic Compression Versus Anti-thromboembolic Exercises for Patients Undergoing Total Hip Arthroplasty
A study testing PC Pneumatic compression and AE Antithromboembolic exercises in people with Edema Leg, run by Luca Marin at 1 site in Italy.
Trial summary
This study is a randomized controlled trial, with two parallel arms. The open-label study will be conducted in accordance with the helsinky statement and good clinical practice standards. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Edema Leg
- What is being tested?
- PC Pneumatic compression and AE Antithromboembolic exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 11 Apr 2022to 30 Sep 2022
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- total hip arthroplasty, scheduled surgery
- aged between 50 and 80 at the time of recruitment
Who cannot join
- obesity (BMI> 30);
- other orthopedic or neurological pathologies that modify walking ability;
- pathologies that modify balance (neurological and / or vestibular);
- contraindications to the use of the medical equipment used in the study;
- inability to understand and sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pneumatic Compression Versus Anti-thromboembolic Exercises: Effects on Edema of the Lower Limbs and the Outcomes of Patients Undergoing Total Hip Arthroplasty: Randomized Controlled Clinical Trial
This study is a randomized controlled trial, with two parallel arms. The open-label study will be conducted in accordance with the helsinky statement and good clinical practice standards.
The main objective is to compare the reduction of postoperative edema following Total Hip Arthroplasty (THA) between patients undergoing postoperative treatment with pneumatic compression (PC, experimental group) and patients undergoing postoperative treatment with antithromboembolic exercises. (AE, control group). We also aim to compare the pre-post treatment variations of joint function measurements (joint excursion), referred pain and functional capabilities.
Read more
48 patients will meet the criteria listed below will be recruited.
Inclusion criteria:
- total hip arthroplasty under election regime
- aged between 50 and 80 at the time of recruitment, both sexes.
Exclusion criteria:
- obesity (BMI> 30);
- other orthopedic or neurological pathologies that modify walking ability;
- pathologies that modify balance (neurological and / or vestibular);
- contraindications to the use of the medical equipment used in the study;
- inability to understand and sign informed consent. Participants will be assigned, through a block randomization, to one of the two study groups: experimental group will undergo pneumatic compression treatment (PC), control group will perform antithromboembolic exercises (AE).
For both, the treatment will last 10 working days, starting from the first post surgery day (T0). The PC will undergo two daily 30-minute sessions of sequential pneumatic compression (I-Press®, I-Tech Medical Division, Martellago, Italy) while AE will perform two supervised antithromboembolic exercises sessions daily lasting 30 minutes. All participants will carry out the antithrombotic prophylaxis in use at the department of orthopedics: drug therapy, graduated compression stocking and indirect electrostimulation (T-One Rehab®, I-Tech Medical Division, Martellago, Italy).
Assessments of edema, joint range of motion, pain and functional capabilities will be made at T0 and at the end of the treatment (T1).
Read the detailed description
This study is a randomized controlled trial, with two parallel arms. The open-label study will be conducted in accordance with the helsinky statement and good clinical practice standards.
To compare the reduction of postoperative edema following Total Hip Arthroplasty (THA) between patients undergoing postoperative treatment with pneumatic compression (PC, experimental group) and patients undergoing postoperative treatment with antithromboembolic exercises. (AE, control group). We also aim to compare the pre-post treatment variations of joint function measurements (joint excursion), referred pain and functional capabilities.
48 patients will be recruited at the Department of Orthopedic Surgery of the City of Pavia, University Hospital.
Participants will be assigned, through a block randomization, to one of the two study groups: experimental group will undergo pneumatic compression treatment (PC), control group will perform antithromboembolic exercises (AE). For both, the treatment will last 10 working days, starting from the first post surgery day (T0). The PC will undergo two daily 30-minute sessions of sequential pneumatic compression (I-Press®, I-Tech Medical Division, Martellago, Italy) while AE will perform two supervised antithromboembolic exercises sessions daily lasting 30 minutes. All participants will carry out the antithrombotic prophylaxis in use at the department of orthopedics: drug therapy, graduated compression stocking and indirect electrostimulation (T-One Rehab®, I-Tech Medical Division, Martellago, Italy).
At T0 and at the end of the treatment (T1) the following assessments of the operated limb will be carried out:
- circumference of the distal third of the thigh
- circumference of the proximal third of the leg
- range of motion of the knee flexion
- range of motion of the ankle dorsiflexion
The following assessments will also be carried out:
- perceived pain, with the Numeric Rating Scale of Pain (NRS)
- functional capability, with 20 m walk test (20 m). Walking autonomy will be carried out at T1 with the 6 minutes walking test (6MWT).
STATISTICAL ANALYSIS Quantitative variables will be described with mean and standard deviation if normally distributed, with median and interquartile range if not normally distributed.
Categorical variables will be expressed with counts and percentages. Continuous variables will be compared between the two groups with Student's t test or with the analogous non-parametric Mann-Whitney test, considering the normality of the distribution (evaluated with graphical methods or with the Shapiro-Wilk test).
Possible associations between categorical variables will be evaluated with Pearson's chi-square test or with Fisher's exact test.
All tests will be two-tailed; the level of significance is set at alpha 0.05 (statistical significance if p value <0.05).
- Conditions
- Edema Leg
- Being tested
- PC Pneumatic compression, AE Antithromboembolic exercises
- Keywords
- Total hip arthroplasty, functional capabilities, Pneumatic compression, antithromboembolic exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC Pneumatic compressionDevice
Also called I-Press®, I-Tech Medical Division, Martellago, Italy
Pneumatic compression of the operated limb
AE Antithromboembolic exercisesOther
Exercises for the edema
| Study group | Role | What they receive |
|---|---|---|
| Pneumatic Compression (PC) | Experimental | The PC will undergo two daily 30-minute sessions of sequential pneumatic compression. Receives: Device: PC Pneumatic compression |
| Antithromboembolic exercises (AE) | Active comparator | AE will perform two supervised antithromboembolic exercises sessions daily lasting 30 minutes. Receives: Other: AE Antithromboembolic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operated limb edema
circumference of the distal third of the thigh
- circumference of the proximal third of the leg circumference of the distal third of the thigh
- circumference of the proximal third of the leg thigh and leg circumference
Measured: Ten days
Secondary outcomes (3)
Perceived Pain
Perceived pain, assessed with Numeric Rating Scale. Where 0 is no pain and 10 is the maximum pain felt
Measured: Ten days
Functional capability
Walking capability, assessed with 20 meters walking test
Measured: Ten Days
Operated lower limb range of motion
Knee and ankle range of motion
Measured: Ten Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start11 Apr 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Edema LegStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luca Marin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luca Marin, University of Pavia
- Investigators
- Luca Marin, PhD, Principal investigator, University fo Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312060
- Sponsor's protocol ID
- 0014626/22
- Status last verified
- May 2022
- First submitted
- 27 Mar 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santana DC, Emara AK, Orr MN, Klika AK, Higuera CA, Krebs VE, Molloy RM, Piuzzi NS. An Update on Venous Thromboembolism Rates and Prophylaxis in Hip and Knee Arthroplasty in 2020. Medicina (Kaunas). 2020 Aug 19;56(9):416. doi: 10.3390/medicina56090416.
PubMed 32824931O'Reilly RF, Burgess IA, Zicat B. The prevalence of venous thromboembolism after hip and knee replacement surgery. Med J Aust. 2005 Feb 21;182(4):154-9. doi: 10.5694/j.1326-5377.2005.tb06643.x.
PubMed 15720169Williams KJ, Ravikumar R, Gaweesh AS, Moore HM, Lifsitz AD, Lane TR, Shalhoub J, Babber A, Davies AH. A Review of the Evidence to Support Neuromuscular Electrical Stimulation in the Prevention and Management of Venous Disease. Adv Exp Med Biol. 2017;906:377-386. doi: 10.1007/5584_2016_128.
PubMed 27620314Westrich GH, Specht LM, Sharrock NE, Sculco TP, Salvati EA, Pellicci PM, Trombley JF, Peterson M. Pneumatic compression hemodynamics in total hip arthroplasty. Clin Orthop Relat Res. 2000 Mar;(372):180-91. doi: 10.1097/00003086-200003000-00020.
PubMed 10738427Berliner JL, Ortiz PA, Lee YY, Miller TT, Westrich GH. Venous Hemodynamics After Total Hip Arthroplasty: A Comparison Between Portable vs Stationary Pneumatic Compression Devices and the Effect of Body Position. J Arthroplasty. 2018 Jan;33(1):162-166. doi: 10.1016/j.arth.2017.08.005. Epub 2017 Aug 24.
PubMed 28927565Pitto RP, Hamer H, Kuhle JW, Radespiel-Troger M, Pietsch M. [Hemodynamics of the lower extremity with pneumatic foot compression. Effect on leg position]. Biomed Tech (Berl). 2001 May;46(5):124-8. doi: 10.1515/bmte.2001.46.5.124. German.
PubMed 11413908Pitto RP, Young S. Foot pumps without graduated compression stockings for prevention of deep-vein thrombosis in total joint replacement: efficacy, safety and patient compliance. A comparative, prospective clinical trial. Int Orthop. 2008 Jun;32(3):331-6. doi: 10.1007/s00264-007-0326-9. Epub 2007 Feb 15.
PubMed 17653546Fujisawa M, Naito M, Asayama I, Kambe T, Koga K. Effect of calf-thigh intermittent pneumatic compression device after total hip arthroplasty: comparative analysis with plantar compression on the effectiveness of reducing thrombogenesis and leg swelling. J Orthop Sci. 2003;8(6):807-11. doi: 10.1007/s00776-003-0706-y.
PubMed 14648269Zhao JM, He ML, Xiao ZM, Li TS, Wu H, Jiang H. Different types of intermittent pneumatic compression devices for preventing venous thromboembolism in patients after total hip replacement. Cochrane Database Syst Rev. 2014 Dec 22;2014(12):CD009543. doi: 10.1002/14651858.CD009543.pub3.
PubMed 25528992Kakkos SK, Caprini JA, Geroulakos G, Nicolaides AN, Stansby G, Reddy DJ, Ntouvas I. Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism. Cochrane Database Syst Rev. 2016 Sep 7;9(9):CD005258. doi: 10.1002/14651858.CD005258.pub3.
PubMed 27600864
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumatic Compression Versus Anti-thromboembolic Exercises: Effects on Edema of the Lower Limbs and the Outcomes of Patients Undergoing Total Hip Arthroplasty: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05312060
- Acronym / sponsor ID
- 0014626/22
- Conditions
- Edema Leg
- Keywords
- Total hip arthroplasty, functional capabilities, Pneumatic compression, antithromboembolic exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Luca MarinUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 5 Apr 2022 (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 a randomized controlled trial, with two parallel arms. The open-label study will be conducted in accordance with the helsinky statement and good clinical practice standards.
The main objective is to compare the reduction of postoperative edema following Total Hip Arthroplasty (THA) between patients undergoing postoperative treatment with pneumatic compression (PC, experimental group) and patients undergoing postoperative treatment with antithromboembolic exercises. (AE, control group). We also aim to compare the pre-post treatment variations of joint function measurements (joint excursion), referred pain and functional capabilities.
48 patients will meet the criteria listed below will be recruited.
Inclusion criteria:
- total hip arthroplasty under election regime
- aged between 50 and 80 at the time of recruitment, both sexes.
Exclusion criteria:
- obesity (BMI> 30);
- other orthopedic or neurological pathologies that modify walking ability;
- pathologies that modify balance (neurological and / or vestibular);
- contraindications to the use of the medical equipment used in the study;
- inability to understand and sign informed consent. Participants will be assigned, through a block randomization, to one of the two study groups: experimental group will undergo pneumatic compression treatment (PC), control group will perform antithromboembolic exercises (AE).
For both, the treatment will last 10 working days, starting from the first post surgery day (T0). The PC will undergo two daily 30-minute sessions of sequential pneumatic compression (I-Press®, I-Tech Medical Division, Martellago, Italy) while AE will perform two supervised antithromboembolic exercises sessions daily lasting 30 minutes. All participants will carry out the antithrombotic prophylaxis in use at the department of orthopedics: drug therapy, graduated compression stocking and indirect electrostimulation (T-One Rehab®, I-Tech Medical Division, Martellago, Italy).
Assessments of edema, joint range of motion, pain and functional capabilities will be made at T0 and at the end of the treatment (T1).
Detailed description
This study is a randomized controlled trial, with two parallel arms. The open-label study will be conducted in accordance with the helsinky statement and good clinical practice standards.
To compare the reduction of postoperative edema following Total Hip Arthroplasty (THA) between patients undergoing postoperative treatment with pneumatic compression (PC, experimental group) and patients undergoing postoperative treatment with antithromboembolic exercises. (AE, control group). We also aim to compare the pre-post treatment variations of joint function measurements (joint excursion), referred pain and functional capabilities.
48 patients will be recruited at the Department of Orthopedic Surgery of the City of Pavia, University Hospital.
Participants will be assigned, through a block randomization, to one of the two study groups: experimental group will undergo pneumatic compression treatment (PC), control group will perform antithromboembolic exercises (AE). For both, the treatment will last 10 working days, starting from the first post surgery day (T0). The PC will undergo two daily 30-minute sessions of sequential pneumatic compression (I-Press®, I-Tech Medical Division, Martellago, Italy) while AE will perform two supervised antithromboembolic exercises sessions daily lasting 30 minutes. All participants will carry out the antithrombotic prophylaxis in use at the department of orthopedics: drug therapy, graduated compression stocking and indirect electrostimulation (T-One Rehab®, I-Tech Medical Division, Martellago, Italy).
At T0 and at the end of the treatment (T1) the following assessments of the operated limb will be carried out:
- circumference of the distal third of the thigh
- circumference of the proximal third of the leg
- range of motion of the knee flexion
- range of motion of the ankle dorsiflexion
The following assessments will also be carried out:
- perceived pain, with the Numeric Rating Scale of Pain (NRS)
- functional capability, with 20 m walk test (20 m). Walking autonomy will be carried out at T1 with the 6 minutes walking test (6MWT).
STATISTICAL ANALYSIS Quantitative variables will be described with mean and standard deviation if normally distributed, with median and interquartile range if not normally distributed.
Categorical variables will be expressed with counts and percentages. Continuous variables will be compared between the two groups with Student's t test or with the analogous non-parametric Mann-Whitney test, considering the normality of the distribution (evaluated with graphical methods or with the Shapiro-Wilk test).
Possible associations between categorical variables will be evaluated with Pearson's chi-square test or with Fisher's exact test.
All tests will be two-tailed; the level of significance is set at alpha 0.05 (statistical significance if p value <0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumatic Compression (PC) | Experimental | Device: PC Pneumatic compressionThe PC will undergo two daily 30-minute sessions of sequential pneumatic compression. |
| Antithromboembolic exercises (AE) | Active comparator | Other: AE Antithromboembolic exercisesAE will perform two supervised antithromboembolic exercises sessions daily lasting 30 minutes. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- total hip arthroplasty, scheduled surgery
- aged between 50 and 80 at the time of recruitment
Key exclusion criteria (5 listed)
- obesity (BMI> 30);
- other orthopedic or neurological pathologies that modify walking ability;
- pathologies that modify balance (neurological and / or vestibular);
- contraindications to the use of the medical equipment used in the study;
- inability to understand and sign informed consent.
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 |
|---|---|---|
| PC Pneumatic compressionAlso: I-Press®, I-Tech Medical Division, Martellago, ItalyPneumatic compression of the operated limb | Device | Pneumatic Compression (PC) |
| AE Antithromboembolic exercisesExercises for the edema | Other | Antithromboembolic exercises (AE) |
Primary outcome
Operated limb edema
Time frame: Ten days
circumference of the distal third of the thigh * circumference of the proximal third of the leg circumference of the distal third of the thigh * circumference of the proximal third of the leg thigh and leg circumference
3 secondary outcomes
Perceived Pain
Time frame: Ten days
Functional capability
Time frame: Ten Days
Operated lower limb range of motion
Time frame: Ten Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Background: PubMed 32824931Santana DC, Emara AK, Orr MN, Klika AK, Higuera CA, Krebs VE, Molloy RM, Piuzzi NS. An Update on Venous Thromboembolism Rates and Prophylaxis in Hip and Knee Arthroplasty in 2020. Medicina (Kaunas). 2020 Aug 19;56(9):416. doi: 10.3390/medicina56090416.
- Background: PubMed 15720169O'Reilly RF, Burgess IA, Zicat B. The prevalence of venous thromboembolism after hip and knee replacement surgery. Med J Aust. 2005 Feb 21;182(4):154-9. doi: 10.5694/j.1326-5377.2005.tb06643.x.
- Background: PubMed 27620314Williams KJ, Ravikumar R, Gaweesh AS, Moore HM, Lifsitz AD, Lane TR, Shalhoub J, Babber A, Davies AH. A Review of the Evidence to Support Neuromuscular Electrical Stimulation in the Prevention and Management of Venous Disease. Adv Exp Med Biol. 2017;906:377-386. doi: 10.1007/5584_2016_128.
- Background: PubMed 10738427Westrich GH, Specht LM, Sharrock NE, Sculco TP, Salvati EA, Pellicci PM, Trombley JF, Peterson M. Pneumatic compression hemodynamics in total hip arthroplasty. Clin Orthop Relat Res. 2000 Mar;(372):180-91. doi: 10.1097/00003086-200003000-00020.
- Background: PubMed 28927565Berliner JL, Ortiz PA, Lee YY, Miller TT, Westrich GH. Venous Hemodynamics After Total Hip Arthroplasty: A Comparison Between Portable vs Stationary Pneumatic Compression Devices and the Effect of Body Position. J Arthroplasty. 2018 Jan;33(1):162-166. doi: 10.1016/j.arth.2017.08.005. Epub 2017 Aug 24.
- Background: PubMed 11413908Pitto RP, Hamer H, Kuhle JW, Radespiel-Troger M, Pietsch M. [Hemodynamics of the lower extremity with pneumatic foot compression. Effect on leg position]. Biomed Tech (Berl). 2001 May;46(5):124-8. doi: 10.1515/bmte.2001.46.5.124. German.
- Background: PubMed 17653546Pitto RP, Young S. Foot pumps without graduated compression stockings for prevention of deep-vein thrombosis in total joint replacement: efficacy, safety and patient compliance. A comparative, prospective clinical trial. Int Orthop. 2008 Jun;32(3):331-6. doi: 10.1007/s00264-007-0326-9. Epub 2007 Feb 15.
- Background: PubMed 14648269Fujisawa M, Naito M, Asayama I, Kambe T, Koga K. Effect of calf-thigh intermittent pneumatic compression device after total hip arthroplasty: comparative analysis with plantar compression on the effectiveness of reducing thrombogenesis and leg swelling. J Orthop Sci. 2003;8(6):807-11. doi: 10.1007/s00776-003-0706-y.
- Background: PubMed 25528992Zhao JM, He ML, Xiao ZM, Li TS, Wu H, Jiang H. Different types of intermittent pneumatic compression devices for preventing venous thromboembolism in patients after total hip replacement. Cochrane Database Syst Rev. 2014 Dec 22;2014(12):CD009543. doi: 10.1002/14651858.CD009543.pub3.
- Background: PubMed 27600864Kakkos SK, Caprini JA, Geroulakos G, Nicolaides AN, Stansby G, Reddy DJ, Ntouvas I. Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism. Cochrane Database Syst Rev. 2016 Sep 7;9(9):CD005258. doi: 10.1002/14651858.CD005258.pub3.
- Declaration of HelsinkiLink provided by the sponsor.
- 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.
Luca Marin, PhD principal investigator
University fo Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PC Pneumatic compression and AE Antithromboembolic exercises in people with Edema Leg, run by Luca Marin at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 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 23 May 2022. 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 Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Operated limb edema (time frame: Ten days). 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 NCT05312060, which also lists 10 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 23 May 2022.