Return of Motor and Sensory BlockadePhase 2NCT03324984

1% Chloroprocaine(PF) vs. Bupivacaine Spinals

A Phase 2 study testing 1% chloroprocaine and 0.75% bupivacaine in people with Return of Motor and Sensory Blockade and Anesthesia, Spinal, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Return of Motor and Sensory Blockade, Anesthesia, Spinal, Decrease Discharge Time Status Post Hemorrhoidectomy
What is being tested?: 1% chloroprocaine and 0.75% bupivacaine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteUnited States
Study dates: 11 Sep 2019to 1 Feb 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient undergoing anorectal procedures
Age 18 and above
American Society of Anesthesiologist Physical Status (ASA), I-III

Who cannot join

Patient refusal
Inability to understand and sign informed consent
Allergic reaction to bupivacaine or other local anesthetics
Coagulopathy (INR >= 1.5)
Use of anticoagulant drugs (Plavix, Coumadin)
Thrombocytopenia (Platelets < 100,000)

Show all 12Show fewer

Infection at the site
Increased intracranial pressure
Unstable spine, Spine abnormalities
History of atypical cholinesterase (CP is metabolized by cholinesterase)
Diagnosis of any disorders (i.e., benign prostatic hyperplasia, cystitis, vulvovaginitis) that would delay voiding
Anticipated procedure time longer than 60 minutes

Trial locations and contacts

1 site in 1 country.

United States1 site

Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Comparison of 1% Chloroprocaine vs. Hyperbaric Bupivacaine Spinals in Patients Undergoing Hemorrhoidectomies in an Ambulatory Surgery Center: A Double-Blind Randomized Controlled Pilot Trial.

Read the detailed description

The use of 1% Chloroprocaine (PF) spinal anesthesia will reduce the recovery times and discharge time of patients undergoing hemorrhoidectomies as compared to 0.75% bupivacaine spinal. The primary objective is to compare the recovery times (return of motor and sensory function) and discharge time (voiding time) between 1% Chloroprocaine and 0.75% bupivacaine spinal anesthesia for hemorrhoidectomies. This is a randomized, prospective study assigning patients to either 1% Chloroprocaine (PF) or 0.75% bupivacaine spinal anesthesia group. Consents for participation in the study will be obtained during the patients' preoperative anesthesia evaluation. There will be no change in the primary anesthetic technique (spinal anesthesia), since these patients routinely get spinal anesthesia for hemorrhoidectomies, however there would be a change in type of local anesthetic administration. On the day of surgery, consented patients will be randomized to one of the two groups. Both the patients and the researcher who recruited the patients and collected the data will be blinded. (Research assistant will hand an enclosed envelop to the anesthesiologists performing the spinal anesthesia with the name of local anesthetic to use) Postoperatively, the PACU nurse will be ask to document return of motor and sensory function in addition to voiding time. At the time of voiding, the nurse will be asked to inform an anesthesiologist (not involved in the case) for a postoperative evaluation and a discharge note. However, if the patient cannot void once there are able to ambulate, then they stay in PACU until they are the last patient in the unit. If still unable to void, the surgeon will be informed and an ultrasound bladder scan will be used to determine the volume of urine and the patient will be straight cath. The patient will be sent home and informed if he or she cannot void by the next day, then they should call the surgeon's office to notify them and go to the emergency room.

For postoperative data collection, the routine 24hr postoperative phone calls in which nurses make to patients will be utilize, however two additional questions will be asked, 1. Presence of nerve pain in the buttocks and thighs shooting down their legs unilaterally or bilaterally, 2. Inability to void, pass flatus or defecate. If any of the symptoms are present, then the nurse will inform an anesthesiologist (not involved in the case) whom will give the patient a call and advise them on treatment protocol. The research assistant will then be informed by the anesthesiologist who made the phone call.

Conditions: Return of Motor and Sensory Blockade, Anesthesia, Spinal, Decrease Discharge Time Status Post Hemorrhoidectomy
Being tested: 1% chloroprocaine, 0.75% bupivacaine
Keywords: Spinal anesthesia, Pain, Chloroprocaine
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

1% chloroprocaineDrug
In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use.
0.75% bupivacaineDrug
Bupivacaine is used on label

Study groups in NCT03324984
Study group	Role	What they receive
1% Chloroprocaine (PF)	Experimental	1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics. Receives: Drug: 1% chloroprocaine
0.75% bupivacaine	Active comparator	0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose. Receives: Drug: 0.75% bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Recovery Time
For this study Recovery time was defined as the time (in minutes) to return of both motor and sensory function, postoperatively. The return of motor function was tested by demonstrating mobility in both lower extremities including hips, knees, and lower legs using the Bromage scale. The return of sensory function was assessed using light touch and/or pinprick techniques on the dermatomes corresponding with the T8-S2 spinal cord segments. The duration in minutes when both sensory and motor function were re-established was documented and results were summarized by study arm using basic descriptive statistics. In this study it is hypothesized that use of 1% Chloroprocaine spinal anesthesia will reduce recovery times of patients undergoing anorectal procedures as compared to 0.75% bupivacaine spinal.
Measured: On post-operative day 1 (POD1), approximately every 15 minutes up to 24 hours
Discharge Time
For this study discharge time is defined as the time (in minutes) when the patient is "fit to discharge" from the Postoperative Care Unit (PACU). At the institution where this study took place "fit to discharge" was defined as the ability to void and the ability to ambulate unassisted for at least 10 feet. The duration of time when a patient was able to do both was documented. Results were summarized by study arm using basic descriptive statistics. It is hypothesized that the use of 1% Chloroprocaine spinal anesthesia will result in a clinically significant 30% reduction in discharge times of patients as compared to 0.75% bupivacaine spinal.
Measured: On post-operative day 1 (POD1), up to 24 hours

Secondary outcomes (2)

Evidence of Hypotension
Evidence of hypotension will be documented if systolic blood pressure (SBP) drops more than 20mmHg from baseline following spinal anesthesia. Hypotension is a common side effect of spinal anesthesia (SA). The number of participants with evidence of hypotension will be summarized by study arm.
Measured: On day of procedure, 0-5 minutes following administration of spinal anesthesia
Evidence of Transient Neurological Symptoms (TNS)
The number of participants demonstrating TNS approximately 24 hours following the procedure will be assessed. TNS will be defined as back pain or dysesthesia that radiated to the buttocks, thighs, hips, or calves and began within the first 24 hours after surgery. Localized pain or tenderness at the injection site or lower back without radiation will not be considered TNS. TNS is clinically important as it causes patient pain and discomfort and, in severe cases, may delay discharge or cause readmission. Symptoms will be summarized and reported by study arm.
Measured: On post-op day 2, approximately 24 hours post operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 20191 Feb 2023

First posted30 Oct 2017
Study start11 Sep 2019
Primary completion1 Feb 2023
Study completion1 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Return of Motor and Sensory BlockadeStudies of the same condition, open and under way.
More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03324984
Sponsor's protocol ID: 2017-8414
Status last verified: Feb 2025
First submitted: 25 Oct 2017
Last updated: 28 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Apfelbaum JL, Walawander CA, Grasela TH, Wise P, McLeskey C, Roizen MF, Wetchler BV, Korttila K. Eliminating intensive postoperative care in same-day surgery patients using short-acting anesthetics. Anesthesiology. 2002 Jul;97(1):66-74. doi: 10.1097/00000542-200207000-00010.
PubMed 12131105
Liu SS, Strodtbeck WM, Richman JM, Wu CL. A comparison of regional versus general anesthesia for ambulatory anesthesia: a meta-analysis of randomized controlled trials. Anesth Analg. 2005 Dec;101(6):1634-1642. doi: 10.1213/01.ANE.0000180829.70036.4F.
PubMed 16301234
Forster JG. Short-acting spinal anesthesia in the ambulatory setting. Curr Opin Anaesthesiol. 2014 Dec;27(6):597-604. doi: 10.1097/ACO.0000000000000126.
PubMed 25211156
Pollock JE. Transient neurologic symptoms: etiology, risk factors, and management. Reg Anesth Pain Med. 2002 Nov-Dec;27(6):581-6. doi: 10.1053/rapm.2002.36457. No abstract available.
PubMed 12430108
Fanelli A, Ghisi D, Allegri M. Is spinal anaesthesia a suitable technique for ultra-short outpatient procedures? Acta Biomed. 2013 Jun 1;84(1):76-80.
PubMed 24189768
Smith KN, Kopacz DJ, McDonald SB. Spinal 2-chloroprocaine: a dose-ranging study and the effect of added epinephrine. Anesth Analg. 2004 Jan;98(1):81-88. doi: 10.1213/01.ANE.0000093361.48458.6E.
PubMed 14693591
Vath JS, Kopacz DJ. Spinal 2-chloroprocaine: the effect of added fentanyl. Anesth Analg. 2004 Jan;98(1):89-94. doi: 10.1213/01.ANE.0000093360.02058.ED.
PubMed 14693593
Kouri ME, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with lidocaine in volunteers. Anesth Analg. 2004 Jan;98(1):75-80. doi: 10.1213/01.ANE.0000093228.61443.EE.
PubMed 14693590
Yoos JR, Kopacz DJ. Spinal 2-chloroprocaine for surgery: an initial 10-month experience. Anesth Analg. 2005 Feb;100(2):553-558. doi: 10.1213/01.ANE.0000130397.38849.4A.
PubMed 15673893
Hejtmanek MR, Pollock JE. Chloroprocaine for spinal anesthesia: a retrospective analysis. Acta Anaesthesiol Scand. 2011 Mar;55(3):267-72. doi: 10.1111/j.1399-6576.2010.02371.x.
PubMed 21288208
Pavlin DJ, Pavlin EG, Fitzgibbon DR, Koerschgen ME, Plitt TM. Management of bladder function after outpatient surgery. Anesthesiology. 1999 Jul;91(1):42-50. doi: 10.1097/00000542-199907000-00010.
PubMed 10422927
Mulroy MF. Outpatients do not need to void after short neuraxial blocks. Anesthesiology. 2009 Dec;111(6):1388; author reply 1389. doi: 10.1097/ALN.0b013e3181bfa8d3. No abstract available.
PubMed 19934900
Lacasse MA, Roy JD, Forget J, Vandenbroucke F, Seal RF, Beaulieu D, McCormack M, Massicotte L. Comparison of bupivacaine and 2-chloroprocaine for spinal anesthesia for outpatient surgery: a double-blind randomized trial. Can J Anaesth. 2011 Apr;58(4):384-91. doi: 10.1007/s12630-010-9450-x. Epub 2011 Jan 4.
PubMed 21203878
Teunkens A, Vermeulen K, Van Gerven E, Fieuws S, Van de Velde M, Rex S. Comparison of 2-Chloroprocaine, Bupivacaine, and Lidocaine for Spinal Anesthesia in Patients Undergoing Knee Arthroscopy in an Outpatient Setting: A Double-Blind Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):576-83. doi: 10.1097/AAP.0000000000000420.
PubMed 27281722
Kim SW, Khandaker R, Muse IO, Pulverenti T, Goman M, Patel J, Yedlin A, Balikai CP, Levine R, Choice C, Montilla Medrano E. Comparison of 1% chloroprocaine hydrochloride versus hyperbaric bupivacaine spinal in patients undergoing anorectal surgery in an ambulatory surgery center: a double-blind randomized clinical trial. Reg Anesth Pain Med. 2026 Mar 5;51(3):324-329. doi: 10.1136/rapm-2024-106130.
PubMed 39740957

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of 1% Chloroprocaine vs. Hyperbaric Bupivacaine Spinals in Patients Undergoing Hemorrhoidectomies in an Ambulatory Surgery Center: A Double-Blind Randomized Controlled Pilot Trial.
ClinicalTrials.gov ID: NCT03324984
Acronym / sponsor ID: 2017-8414
Conditions: Return of Motor and Sensory Blockade, Anesthesia, Spinal, Decrease Discharge Time Status Post Hemorrhoidectomy
Keywords: Spinal anesthesia, Pain, Chloroprocaine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Study start: 11 Sep 2019 (actual)
Primary completion: 1 Feb 2023 (actual)
Study completion: 1 Feb 2023 (actual)
First posted: 30 Oct 2017 (actual)
Results: Posted 28 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
1% Chloroprocaine (PF)	Experimental	Drug: 1% chloroprocaine1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics.
0.75% bupivacaine	Active comparator	Drug: 0.75% bupivacaine0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient undergoing anorectal procedures
Age 18 and above
American Society of Anesthesiologist Physical Status (ASA), I-III

Key exclusion criteria (12 listed)

Patient refusal
Inability to understand and sign informed consent
Allergic reaction to bupivacaine or other local anesthetics
Coagulopathy (INR >= 1.5)
Use of anticoagulant drugs (Plavix, Coumadin)

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
1% chloroprocaineIn 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use.	Drug	1% Chloroprocaine (PF)
0.75% bupivacaineBupivacaine is used on label	Drug	0.75% bupivacaine

Primary outcome

Recovery Time
Time frame: On post-operative day 1 (POD1), approximately every 15 minutes up to 24 hours
For this study Recovery time was defined as the time (in minutes) to return of both motor and sensory function, postoperatively. The return of motor function was tested by demonstrating mobility in both lower extremities including hips, knees, and lower legs using the Bromage scale. The return of sensory function was assessed using light touch and/or pinprick techniques on the dermatomes corresponding with the T8-S2 spinal cord segments. The duration in minutes when both sensory and motor function were re-established was documented and results were summarized by study arm using basic descriptive statistics. In this study it is hypothesized that use of 1% Chloroprocaine spinal anesthesia will reduce recovery times of patients undergoing anorectal procedures as compared to 0.75% bupivacaine spinal.
Discharge Time
Time frame: On post-operative day 1 (POD1), up to 24 hours
For this study discharge time is defined as the time (in minutes) when the patient is "fit to discharge" from the Postoperative Care Unit (PACU). At the institution where this study took place "fit to discharge" was defined as the ability to void and the ability to ambulate unassisted for at least 10 feet. The duration of time when a patient was able to do both was documented. Results were summarized by study arm using basic descriptive statistics. It is hypothesized that the use of 1% Chloroprocaine spinal anesthesia will result in a clinically significant 30% reduction in discharge times of patients as compared to 0.75% bupivacaine spinal.

2 secondary outcomes

Evidence of Hypotension
Time frame: On day of procedure, 0-5 minutes following administration of spinal anesthesia
Evidence of Transient Neurological Symptoms (TNS)
Time frame: On post-op day 2, approximately 24 hours post operation

Results and safety

Results posted to the registry on 28 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1% Chloroprocaine (PF)	55	54
0.75% Bupivacaine	55	51

Primary outcome: Recovery Time

Time frame: On post-operative day 1 (POD1), approximately every 15 minutes up to 24 hours. Mean (Standard Error). Unit: minutes

Measure	1% Chloroprocaine (PF) n = 54	0.75% Bupivacaine n = 51
Value	134.1 (8.6)	161.9 (10.3)

Primary outcome: Discharge Time

Time frame: On post-operative day 1 (POD1), up to 24 hours. Mean (Standard Error). Unit: minutes

Measure	1% Chloroprocaine (PF) n = 54	0.75% Bupivacaine n = 51
Value	191.4 (6.6)	230.9 (9.4)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 48 hours following procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1% Chloroprocaine (PF)	0 of 54 (0%)	0 of 54 (0%)	0 of 54
0.75% Bupivacaine	0 of 51 (0%)	0 of 51 (0%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12131105Apfelbaum JL, Walawander CA, Grasela TH, Wise P, McLeskey C, Roizen MF, Wetchler BV, Korttila K. Eliminating intensive postoperative care in same-day surgery patients using short-acting anesthetics. Anesthesiology. 2002 Jul;97(1):66-74. doi: 10.1097/00000542-200207000-00010.
Background: PubMed 16301234Liu SS, Strodtbeck WM, Richman JM, Wu CL. A comparison of regional versus general anesthesia for ambulatory anesthesia: a meta-analysis of randomized controlled trials. Anesth Analg. 2005 Dec;101(6):1634-1642. doi: 10.1213/01.ANE.0000180829.70036.4F.
Background: PubMed 25211156Forster JG. Short-acting spinal anesthesia in the ambulatory setting. Curr Opin Anaesthesiol. 2014 Dec;27(6):597-604. doi: 10.1097/ACO.0000000000000126.
Background: PubMed 12430108Pollock JE. Transient neurologic symptoms: etiology, risk factors, and management. Reg Anesth Pain Med. 2002 Nov-Dec;27(6):581-6. doi: 10.1053/rapm.2002.36457. No abstract available.
Background: PubMed 24189768Fanelli A, Ghisi D, Allegri M. Is spinal anaesthesia a suitable technique for ultra-short outpatient procedures? Acta Biomed. 2013 Jun 1;84(1):76-80.
Background: PubMed 14693591Smith KN, Kopacz DJ, McDonald SB. Spinal 2-chloroprocaine: a dose-ranging study and the effect of added epinephrine. Anesth Analg. 2004 Jan;98(1):81-88. doi: 10.1213/01.ANE.0000093361.48458.6E.
Background: PubMed 14693593Vath JS, Kopacz DJ. Spinal 2-chloroprocaine: the effect of added fentanyl. Anesth Analg. 2004 Jan;98(1):89-94. doi: 10.1213/01.ANE.0000093360.02058.ED.
Background: PubMed 14693590Kouri ME, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with lidocaine in volunteers. Anesth Analg. 2004 Jan;98(1):75-80. doi: 10.1213/01.ANE.0000093228.61443.EE.
Background: PubMed 15673893Yoos JR, Kopacz DJ. Spinal 2-chloroprocaine for surgery: an initial 10-month experience. Anesth Analg. 2005 Feb;100(2):553-558. doi: 10.1213/01.ANE.0000130397.38849.4A.
Background: PubMed 21288208Hejtmanek MR, Pollock JE. Chloroprocaine for spinal anesthesia: a retrospective analysis. Acta Anaesthesiol Scand. 2011 Mar;55(3):267-72. doi: 10.1111/j.1399-6576.2010.02371.x.
Background: PubMed 10422927Pavlin DJ, Pavlin EG, Fitzgibbon DR, Koerschgen ME, Plitt TM. Management of bladder function after outpatient surgery. Anesthesiology. 1999 Jul;91(1):42-50. doi: 10.1097/00000542-199907000-00010.
Background: PubMed 19934900Mulroy MF. Outpatients do not need to void after short neuraxial blocks. Anesthesiology. 2009 Dec;111(6):1388; author reply 1389. doi: 10.1097/ALN.0b013e3181bfa8d3. No abstract available.
Individual participant dataSharing planned: No

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.

Elilary Montilla Medrano, MD principal investigator

Montefiore Medicial Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 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: finished, as of the sponsor's last update on 28 Feb 2025. 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 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Recovery Time (time frame: On post-operative day 1 (POD1), approximately every 15 minutes up to 24 hours). The study lists 2 primary outcomes in all. 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 NCT03324984, which also lists 15 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 28 Feb 2025.