Pregnant WomenPhase 3NCT02973048
Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia
A Phase 3 study testing Hyperbaric bupivacaine and Hyperbaric prilocaine in people with Pregnant Women and Pain, run by Centre Hospitalier Universitaire Saint Pierre at 2 sites in Belgium.
Trial summary
Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite effective surgical anesthesia, bupivacaine is associated with long duration motor block and dose-dependent maternal hypotension… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnant Women, Pain, Hypotension
- What is being tested?
- Hyperbaric bupivacaine and Hyperbaric prilocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesBelgium
- Study dates
- 12 Mar 2018to 8 Nov 2018
- Phase
- Phase 3
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status (ASA) < III
- Age 18-40 year
- Body Weight <110 kg
- Height between 160 and 175 cm
- Gestational age>37 SA
- Elective cesarean delivery
Show all 9Show fewer
- Singleton pregnancy
- Non complicated pregnancy
- Signed informed consent obtained prior to any study specific assessments and procedures
Who cannot join
- Twin pregnancy
- History of 2 cesarean section or more
- Diabetes and gestational diabetes
- Placenta praevia
- Congenital foetal abnormality
- Intrauterine growth retardation
Show all 14Show fewer
- Patient in labour
- Membrane rupture
- Known allergy to local anaesthetics
- Standard contraindications to neuraxial block.
- Disagreement of the patient
- Neurological impairment
- Gestational low blood pressure
- Pre eclampsia and eclampsia
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Clinique Ste-Anne/St-Remi
Anderlecht, 1070
University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)
Brussels, Brussels Capital, 1000
About this study
Official title: Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia: a Randomised Clinical Trial
Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite effective surgical anesthesia, bupivacaine is associated with long duration motor block and dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and faster regression of motor block compared to other local anesthetics without noteworthy side-effects when used intrathecally. The aim of this randomized, multicenter, powered clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric bupivacaine for scheduled caesarean delivery under spinal anesthesia, with more rapid rehabilitation and less adverse effects. Our hypothesis is that hyperbaric prilocaine offers shorter motor block and more rapid rehabilitation than bupivacaine.
- Conditions
- Pregnant Women, Pain, Hypotension
- Being tested
- Hyperbaric bupivacaine, Hyperbaric prilocaine
- Keywords
- Cesarean delivery, Spinal anesthesia, Local anesthetics
- Medical subject headings
- Pain, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric bupivacaineDrug
Also called Marcaine
The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
Hyperbaric prilocaineDrug
Also called Tachipri
The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric bupivacaine | Placebo comparator | Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl. Receives: Drug: Hyperbaric bupivacaine |
| Hyperbaric prilocaine | Active comparator | Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl. Receives: Drug: Hyperbaric prilocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Regression of Motor Block
Time to regression of motor block is the time between maximal blockade (score 1, as evaluated by the Modified Bromage scale), and no blockade (score 6). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia, then every 15 minutes until the end of surgery, and thereafter, every 30 minutes until complete regression of motor block
Measured: until complete regression of motor block (up to 4 hours)
Secondary outcomes (21)
Time to Successful Anesthesia (Successful Sensory Block)
Time between spinal injection and reached bilateral T4 sensory level.
Measured: From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes)
Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
Level of Sensory block is assessed as loss of sensation to cold, and represents the dermatomal level under which anesthesia is effective. It is measured every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, thereafter, once 30 minutes until total regression of sensory block (T12-S1). A dermatome is the area of skin that is supplied by a single spinal nerve - Dermatome levels : C5-C8 for Cervical levels and T1-T4 for Thoracic levels.
To perform cesarean section loss of cold sensation at a dermatome of at least T4 has to be obtained.
The results are expressed as the number of patients reaching each dermatomal level from T4 and above (see below) as maximal sensory level, this is a usual outcome used to evaluate the quality of anesthesia.
Measured: until complete release of sensory block (T12-S1) (average 4 hours)
Time to Resolution of Sensory Block
Evaluation at every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, and thereafter, every 30 minutes until total regression of sensory block (T12-S1).
Measured: until complete release of sensory block (T12-S1) (average 4 hours)
Time to Motor Block Onset
Time of installation of the motor block (time between spinal injection and maximum motor block of 1, as evaluated by the Modified Bromage scale). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia
Measured: From spinal injection of the local anesthetic to bilateral T4 level and during surgery (average 1 hour)
Number of Patients With Hypotension and Use of Vasopressors
Arterial blood pressure will be measured at every 1 minute during the first 15 minutes, then at every 2.5 minutes until the end of surgery, and at every 20 minutes in the Post Anesthesia Care Unit (PACU). A low blood pressure (hypotension) is defined as a systolic blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia)
Measured: up to 2 hours after surgery
Number of Participants With Urinary Retention
All parturients will be questioned and examined for urinary retention (yes or no)
Measured: up to 4 hours after surgery
Time to First Walk
Time for the patients to be able to walk in their room then in the hallway without any assistance for the first time.
Measured: up to 24h after surgery
Maternal Satisfaction Assessed by Visual Analogic Scale (VASS)
All patients will be asked to rate their satisfaction about anesthetic technique during surgery and in the arrival in the Post Anesthesia Care Unit (PACU). Satisfaction evaluated by Visual analog scale (0 cm= very unsatisfied and 10cm = very satisfied)
Measured: up to 24 hours after surgery
Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR)
Maternal rehabilitation is evaluated at postoperative Day1, postoperative Day 2 and postoperative Day 3. Evaluation by Visual analog scale (0 cm= very poor and 10cm = excellent)
Measured: up to 72 hours after surgery
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Evaluation from 15 minutes after spinal injection to the end of surgery, then every 4 hours for 24 hours, then once a day for 3 days (score 0=no symptom; 1=symptom with no necessary treatment; 2=symptom present and treated)
Measured: up to 72 hours after surgery
Number of Participants With Transient Neurologic Symptoms (TNS)
Evaluation of apparition of TNS at postoperative Day 1, postoperative Day 2, postoperative Day 3 and postoperative Day 15. TNS are defined as pain and/or dysesthesia occurred after complete release of sensory block at the gluteal level, at the thighs and at the legs.
Measured: up to 15 Days after surgery
Pain as Assessed by Visual Analogue Scale
Pain levels will be determined at incision, baby delivery, peritoneal and skin closure, every 5 minutes during surgery, and thereafter every 4 hours for 24 hours. Visual analog pain score (scale = 0 no pain; 10 = worst pain imaginable). Patient will receive additional analgesic treatment above VAS>3.
Measured: up to 24 hours after surgery
Newborn Apgar Score
Newborn Apgar score assessed at 1, 5, 10 minutes after baby extraction. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from 0 to 2, then summing up the five values thus obtained. The overall resulting score ranges from 0 to 10 ( 0-3 : severely depressed, 4-6 : Moderately depressed and 7-10 : Excellent condition).
The five criteria are summarized using words chosen to form an abbreviation (Appearance, Pulse, Grimace, Activity, Respiration).
Measured: up to 10 minutes after baby extraction
Newborn Methemoglobinemia (MetHb)
Newborn Methemoglobinemia (MetHb) will be assessed at delivery by cordal blood sample, as a routine control in obstetrics, and expressed as a percentage of total hemoglobinemia.
Methemoglobinemia (MetHb) is a blood disorder in which an abnormal amount of methemoglobin (hemoglobin in the form metalloprotein) is produced. This specific type of of Hemoglobin carries oxygen through your blood but doesn't release it to the cells.
Measured: average 1 hour
Newborn Umbilical pH
Newborn umbilical pH will be assessed at delivery by cordal blood sample, as a routine control, and expressed as standard value
Measured: average 1 hour
Time of Surgery
Time between incision and end of surgery
Measured: average 1 hour
Time From Spinal Injection to Baby Delivery
Time between spinal injection and baby delivery
Measured: average 1 hour
Time From Baby Delivery to End of Surgery
Time between baby delivery, and the end of surgery
Measured: average 1 hour
Total Blood Loss
Total blood loss (milliliters) during surgery
Measured: average 1 hour
Obstetrician Satisfaction
Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at the end of surgery
Measured: average 1 hour
Midwife Satisfaction
Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at postoperative Day 3
Measured: 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study start12 Mar 2018
- Primary completion8 Nov 2018
- Study completion8 Nov 2018
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 (4)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Panayota KAPESSIDOU, MD, PhD, Study director, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)Philippe GOFFARD, MD, Principal investigator, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973048
- Sponsor's protocol ID
- B076201627677
- Status last verified
- Jul 2020
- First submitted
- 25 Jul 2016
- Last updated
- 2 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gautier P, De Kock M, Huberty L, Demir T, Izydorczic M, Vanderick B. Comparison of the effects of intrathecal ropivacaine, levobupivacaine, and bupivacaine for Caesarean section. Br J Anaesth. 2003 Nov;91(5):684-9. doi: 10.1093/bja/aeg251.
PubMed 14570791Guntz E, Latrech B, Tsiberidis C, Gouwy J, Kapessidou Y. ED50 and ED90 of intrathecal hyperbaric 2% prilocaine in ambulatory knee arthroscopy. Can J Anaesth. 2014 Sep;61(9):801-7. doi: 10.1007/s12630-014-0189-7. Epub 2014 Jun 7.
PubMed 24906303Guntz E, Kapessidou Y. Spinal prilocaine for same-day surgery: the importance of equipotent doses. Can J Anaesth. 2016 Aug;63(8):985-6. doi: 10.1007/s12630-016-0645-7. Epub 2016 Apr 4. No abstract available.
PubMed 27044397Goffard P, Leloup R, Vercruysse Y, Fils JF, Gautier PE, Kapessidou Y. Comparison of equipotent doses of intrathecal hyperbaric prilocaine 2% and hyperbaric bupivacaine 0.5% for elective caesarean section: A prospective, randomised, controlled, two-centre clinical trial. Eur J Anaesthesiol. 2022 Mar 1;39(3):227-235. doi: 10.1097/EJA.0000000000001548.
PubMed 34101713
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT02973048
- Acronym / sponsor ID
- B076201627677
- Conditions
- Pregnant Women, Pain, Hypotension
- Keywords
- Cesarean delivery, Spinal anesthesia, Local anesthetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Posted 2 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite effective surgical anesthesia, bupivacaine is associated with long duration motor block and dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and faster regression of motor block compared to other local anesthetics without noteworthy side-effects when used intrathecally. The aim of this randomized, multicenter, powered clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric bupivacaine for scheduled caesarean delivery under spinal anesthesia, with more rapid rehabilitation and less adverse effects. Our hypothesis is that hyperbaric prilocaine offers shorter motor block and more rapid rehabilitation than bupivacaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric bupivacaine | Placebo comparator | Drug: Hyperbaric bupivacaineHyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl. |
| Hyperbaric prilocaine | Active comparator | Drug: Hyperbaric prilocaineHyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- American Society of Anesthesiologists physical status (ASA) < III
- Age 18-40 year
- Body Weight <110 kg
- Height between 160 and 175 cm
- Gestational age>37 SA
Key exclusion criteria (14 listed)
- Twin pregnancy
- History of 2 cesarean section or more
- Diabetes and gestational diabetes
- Placenta praevia
- Congenital foetal abnormality
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 |
|---|---|---|
| Hyperbaric bupivacaineAlso: MarcaineThe dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points. | Drug | Hyperbaric bupivacaine |
| Hyperbaric prilocaineAlso: TachipriThe dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points. | Drug | Hyperbaric prilocaine |
Primary outcome
Time to Regression of Motor Block
Time frame: until complete regression of motor block (up to 4 hours)
Time to regression of motor block is the time between maximal blockade (score 1, as evaluated by the Modified Bromage scale), and no blockade (score 6). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia, then every 15 minutes until the end of surgery, and thereafter, every 30 minutes until complete regression of motor block
21 secondary outcomes
Time to Successful Anesthesia (Successful Sensory Block)
Time frame: From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes)
Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
Time frame: until complete release of sensory block (T12-S1) (average 4 hours)
Time to Resolution of Sensory Block
Time frame: until complete release of sensory block (T12-S1) (average 4 hours)
Time to Motor Block Onset
Time frame: From spinal injection of the local anesthetic to bilateral T4 level and during surgery (average 1 hour)
Number of Patients With Hypotension and Use of Vasopressors
Time frame: up to 2 hours after surgery
Number of Participants With Urinary Retention
Time frame: up to 4 hours after surgery
Time to First Walk
Time frame: up to 24h after surgery
Maternal Satisfaction Assessed by Visual Analogic Scale (VASS)
Time frame: up to 24 hours after surgery
Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR)
Time frame: up to 72 hours after surgery
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Time frame: up to 72 hours after surgery
Number of Participants With Transient Neurologic Symptoms (TNS)
Time frame: up to 15 Days after surgery
Pain as Assessed by Visual Analogue Scale
Time frame: up to 24 hours after surgery
Newborn Apgar Score
Time frame: up to 10 minutes after baby extraction
Newborn Methemoglobinemia (MetHb)
Time frame: average 1 hour
Newborn Umbilical pH
Time frame: average 1 hour
Time of Surgery
Time frame: average 1 hour
Time From Spinal Injection to Baby Delivery
Time frame: average 1 hour
Time From Baby Delivery to End of Surgery
Time frame: average 1 hour
Total Blood Loss
Time frame: average 1 hour
Obstetrician Satisfaction
Time frame: average 1 hour
Midwife Satisfaction
Time frame: 72 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14570791Gautier P, De Kock M, Huberty L, Demir T, Izydorczic M, Vanderick B. Comparison of the effects of intrathecal ropivacaine, levobupivacaine, and bupivacaine for Caesarean section. Br J Anaesth. 2003 Nov;91(5):684-9. doi: 10.1093/bja/aeg251.
- Background: PubMed 24906303Guntz E, Latrech B, Tsiberidis C, Gouwy J, Kapessidou Y. ED50 and ED90 of intrathecal hyperbaric 2% prilocaine in ambulatory knee arthroscopy. Can J Anaesth. 2014 Sep;61(9):801-7. doi: 10.1007/s12630-014-0189-7. Epub 2014 Jun 7.
- Background: PubMed 27044397Guntz E, Kapessidou Y. Spinal prilocaine for same-day surgery: the importance of equipotent doses. Can J Anaesth. 2016 Aug;63(8):985-6. doi: 10.1007/s12630-016-0645-7. Epub 2016 Apr 4. No abstract available.
- Derived from this study: PubMed 34101713Goffard P, Leloup R, Vercruysse Y, Fils JF, Gautier PE, Kapessidou Y. Comparison of equipotent doses of intrathecal hyperbaric prilocaine 2% and hyperbaric bupivacaine 0.5% for elective caesarean section: A prospective, randomised, controlled, two-centre clinical trial. Eur J Anaesthesiol. 2022 Mar 1;39(3):227-235. doi: 10.1097/EJA.0000000000001548.
- 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.
Panayota KAPESSIDOU, MD, PhD study director
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Philippe GOFFARD, MD principal investigator
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyperbaric bupivacaine and Hyperbaric prilocaine in people with Pregnant Women and Pain, run by Centre Hospitalier Universitaire Saint Pierre at 2 sites in Belgium.
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 9 inclusion and 14 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 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 2 Jul 2020). 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?
Time to Regression of Motor Block (time frame: until complete regression of motor block (up to 4 hours)). 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 NCT02973048, which also lists 4 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 2 Jul 2020.