Intervention Affecting Autonomic Nervous SystemNCT01927380
Autonomic Nervous System Modulation During Laparoscopic Prostatectomy
An observational study of Intervention Affecting Autonomic Nervous System, run by ASST Fatebenefratelli Sacco at 1 site in Italy.
Trial summary
The purpose of this study is to measure the variations of autonomic nervous system (ANS) modulation directed to the heart and vessels induced by pneumoperitoneum and steep trendelenburg position. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Intervention Affecting Autonomic Nervous System
- What is being tested?
- steep trendelenburg position with pneumoperitoneum
- Type of treatment
- Injection or infusion
- How many people
- 37 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2013to Mar 2014
- Phase
- Observational
- 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 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Human males undergoing elective laparoscopic prostatectomy
Who may be able to join
- males scheduled for elective laparoscopic prostatectomy
- sinus rhythm at ECG
- ectopic heart beats <5% of all heart beats
- american society of anesthesiologists status 1-3
Who cannot join
- autonomic dysfunction (documented or suspected)
- adrenal or thyroid dysfunction
- organ dysfunction secondary to diabetes (i.e. nephropathy, retinopathy, neuropathy)
- history of stroke, traumatic spinal injury, heart surgery or major vascular surgery
- intracranial hypertension (documented or suspected)
- hydrocephalus
Show all 10Show fewer
- cardiac functional status ≥NYHA IIb
- non sinusal heart rhythm
- ectopic heart beats ≥5% of normal heart beats
- therapy with beta-blockers or beta2-agonists
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera "Luigi Sacco" - Polo Universitario - University of Milan
Milan, 20157
About this study
The purpose of this study is to measure the variations of autonomic nervous system (ANS) modulation directed to the heart and vessels induced by pneumoperitoneum and steep trendelenburg position.
Read the detailed description
The association of pneumoperitoneum and steep trendelenburg position, commonly used during laparoscopic radical prostatectomy, leads to significant changes in hemodynamics. Many studies found modifications of cardiac output, stroke work index, arterial pressure, central vein pressure and wedge pressure. Moreover, there are reports of severe bradycardia and cardiac arrest following pneumoperitoneum in association with steep trendelenburg. A vagal hypertone (induced by the combination of these two factors) or sympathetic hypractivity (elicited by pneumoperitoneum) had been alternatively postulated to cause these hemodynamic changes. To date there are not sufficient physiologic evidences of modification of ANS activity during steep trendelenburg position in association with pneumoperitoneum.
ANS modulation is studied non invasively by means of heart rate variability and baroreflex sensitivity. Beat-to-beat intervals are computed detecting the QRS complex on the ECG and locating the R-apex using parabolic interpolation. The maximum arterial pressure within each R-to-R interval is taken as systolic arterial pressure (SAP). Sequences of 300 values are randomly selected inside each experimental condition. The power spectrum is estimated according to a univariate parametric approach fitting the series to an autoregressive model. Autoregressive spectral density is factorized into components each of them characterized by a central frequency. A spectral component is labeled as LF if its central frequency is between 0.04 and 0.15 Hz, while it is classified as HF if its central frequency is between 0.15 and 0.4 Hz. The HF power of R-to-R series is utilized as a marker of vagal modulation directed to the heart , while the LF power of SAP series is utilized as a marker of sympathetic modulation directed to vessels. The ratio of the LF power to the HF power assessed from R-to-R series is taken as an indicator simpatho-vagal balance directed to the heart. Baroreflex control in the low frequencies is computed as the square root of the ratio of LF(RR) to LF(SAP). Similarly baroreflex control in the high frequencies is defined as the square root of the ratio of HF(RR) to HF(SAP).
The optic nerve sheet's diameter is assessed echographically after induction of general anesthesia and at the end of the surgery.
Management of general anesthesia is standardized:
- induction with propofol 1.5-2 mg/kg, Remifentanil Target Controlled Infusion (TCI) Ce 4 ng/ml , neuromuscolar blockade with cisatracurium 0.2 mg/kg.
- Maintenance: Sevoflurane 0.6-1.5 MAC (State Entropy target: 40-60); Remifentanil TCI (range Ce 3-15 ng/ml) (Surgical Pleth Index target: 20-50).
- mechanical ventilation at respiratory rate ≥14 breats/min, with tidal volume adjusted to maintain end-tidal carbon dioxide at 32-38 mmHg, and Pplateu <32 cmH2O.
Sample size:
to detect a difference in LF/HF ratio of 0.8 with a SD of 1.7, a power of 0.80 and type I error of 0.05, 37 patients are needed.
- Being tested
- steep trendelenburg position with pneumoperitoneum
- Keywords
- autonomic nervous system modulation, heart rate variability, prostatectomy, steep trendelenburg, pneumoperitoneum
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steep trendelenburg position with pneumoperitoneumOther
ANS activity and baroreflex modulation is assessed at (i) baseline; (ii) after induction of general anesthesia; (iii) after steep trendelenburg position (head down at 25 degrees); (iv) after induction of pneumoperitoneum and (v) after removal of trendelenburg and pneumoperitoneum
| Study group | Role | What they receive |
|---|---|---|
| brachytherapy | males undergoing elective laparoscopic radical prostatectomy steep trendelenburg position with pneumoperitoneum Receives: Other: steep trendelenburg position with pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the changes of ANS modulation directed to the heart and to the vessels, and the changes of baroreflex control induced by steep trendelenburg position and pneumoperitoneum
Measured: Day of surgery
Secondary outcomes (1)
To measure the correlation between ANS changes and hemodynamics
Measured: day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Intervention Affecting Autonomic Nervous SystemStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Fatebenefratelli Sacco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Colombo, ASST Fatebenefratelli Sacco
- Investigators
- Ferdinando Raimondi, Director, Study chair, Azienda Ospedaliera "L.Sacco"Riccardo Colombo, Consultant, Principal investigator, Azienda Ospedaliera "L.Sacco"Stefano Guzzetti, Director, Study director, Azienda Ospedaliera "L.Sacco"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927380
- Sponsor's protocol ID
- CE#371/2013
- Status last verified
- Nov 2014
- First submitted
- 15 Aug 2013
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Falabella A, Moore-Jeffries E, Sullivan MJ, Nelson R, Lew M. Cardiac function during steep Trendelenburg position and CO2 pneumoperitoneum for robotic-assisted prostatectomy: a trans-oesophageal Doppler probe study. Int J Med Robot. 2007 Dec;3(4):312-5. doi: 10.1002/rcs.165.
PubMed 18200624Ficarra V, Novara G, Artibani W, Cestari A, Galfano A, Graefen M, Guazzoni G, Guillonneau B, Menon M, Montorsi F, Patel V, Rassweiler J, Van Poppel H. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: a systematic review and cumulative analysis of comparative studies. Eur Urol. 2009 May;55(5):1037-63. doi: 10.1016/j.eururo.2009.01.036. Epub 2009 Jan 25.
PubMed 19185977Park EY, Koo BN, Min KT, Nam SH. The effect of pneumoperitoneum in the steep Trendelenburg position on cerebral oxygenation. Acta Anaesthesiol Scand. 2009 Aug;53(7):895-9. doi: 10.1111/j.1399-6576.2009.01991.x. Epub 2009 May 6.
PubMed 19426238Awad H, Santilli S, Ohr M, Roth A, Yan W, Fernandez S, Roth S, Patel V. The effects of steep trendelenburg positioning on intraocular pressure during robotic radical prostatectomy. Anesth Analg. 2009 Aug;109(2):473-8. doi: 10.1213/ane.0b013e3181a9098f.
PubMed 19608821Amini A, Kariman H, Arhami Dolatabadi A, Hatamabadi HR, Derakhshanfar H, Mansouri B, Safari S, Eqtesadi R. Use of the sonographic diameter of optic nerve sheath to estimate intracranial pressure. Am J Emerg Med. 2013 Jan;31(1):236-9. doi: 10.1016/j.ajem.2012.06.025. Epub 2012 Aug 31.
PubMed 22944553Lestar M, Gunnarsson L, Lagerstrand L, Wiklund P, Odeberg-Wernerman S. Hemodynamic perturbations during robot-assisted laparoscopic radical prostatectomy in 45 degrees Trendelenburg position. Anesth Analg. 2011 Nov;113(5):1069-75. doi: 10.1213/ANE.0b013e3182075d1f. Epub 2011 Jan 13.
PubMed 21233502Haas S, Haese A, Goetz AE, Kubitz JC. Haemodynamics and cardiac function during robotic-assisted laparoscopic prostatectomy in steep Trendelenburg position. Int J Med Robot. 2011 Dec;7(4):408-13. doi: 10.1002/rcs.410. Epub 2011 Aug 3.
PubMed 21815239Crystal GJ, Salem MR. The Bainbridge and the "reverse" Bainbridge reflexes: history, physiology, and clinical relevance. Anesth Analg. 2012 Mar;114(3):520-32. doi: 10.1213/ANE.0b013e3182312e21. Epub 2011 Sep 29.
PubMed 21965361Montano N, Ruscone TG, Porta A, Lombardi F, Pagani M, Malliani A. Power spectrum analysis of heart rate variability to assess the changes in sympathovagal balance during graded orthostatic tilt. Circulation. 1994 Oct;90(4):1826-31. doi: 10.1161/01.cir.90.4.1826.
PubMed 7923668Pagani M, Lombardi F, Guzzetti S, Rimoldi O, Furlan R, Pizzinelli P, Sandrone G, Malfatto G, Dell'Orto S, Piccaluga E, et al. Power spectral analysis of heart rate and arterial pressure variabilities as a marker of sympatho-vagal interaction in man and conscious dog. Circ Res. 1986 Aug;59(2):178-93. doi: 10.1161/01.res.59.2.178.
PubMed 2874900Pagani M, Montano N, Porta A, Malliani A, Abboud FM, Birkett C, Somers VK. Relationship between spectral components of cardiovascular variabilities and direct measures of muscle sympathetic nerve activity in humans. Circulation. 1997 Mar 18;95(6):1441-8. doi: 10.1161/01.cir.95.6.1441.
PubMed 9118511Ray CA; New Collective Author. Interaction of the vestibular system and baroreflexes on sympathetic nerve activity in humans. Am J Physiol Heart Circ Physiol. 2000 Nov;279(5):H2399-404. doi: 10.1152/ajpheart.2000.279.5.H2399.
PubMed 11045977Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
PubMed 8598068Colombo R, Agarossi A, Borghi B, Ottolina D, Bergomi P, Ballone E, Minari C, Della Porta V, Menozzi E, Figini S, Fossali T, Catena E. The effect of prolonged steep head-down laparoscopy on the optical nerve sheath diameter. J Clin Monit Comput. 2020 Dec;34(6):1295-1302. doi: 10.1007/s10877-019-00418-5. Epub 2019 Nov 5.
PubMed 31691148
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Nervous System Modulation During Laparoscopic Prostatectomy
- ClinicalTrials.gov ID
- NCT01927380
- Acronym / sponsor ID
- CE#371/2013
- Keywords
- autonomic nervous system modulation, heart rate variability, prostatectomy, steep trendelenburg, pneumoperitoneum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- ASST Fatebenefratelli SaccoUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 22 Aug 2013 (estimated)
- 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.
The purpose of this study is to measure the variations of autonomic nervous system (ANS) modulation directed to the heart and vessels induced by pneumoperitoneum and steep trendelenburg position.
Detailed description
The association of pneumoperitoneum and steep trendelenburg position, commonly used during laparoscopic radical prostatectomy, leads to significant changes in hemodynamics. Many studies found modifications of cardiac output, stroke work index, arterial pressure, central vein pressure and wedge pressure. Moreover, there are reports of severe bradycardia and cardiac arrest following pneumoperitoneum in association with steep trendelenburg. A vagal hypertone (induced by the combination of these two factors) or sympathetic hypractivity (elicited by pneumoperitoneum) had been alternatively postulated to cause these hemodynamic changes. To date there are not sufficient physiologic evidences of modification of ANS activity during steep trendelenburg position in association with pneumoperitoneum.
ANS modulation is studied non invasively by means of heart rate variability and baroreflex sensitivity. Beat-to-beat intervals are computed detecting the QRS complex on the ECG and locating the R-apex using parabolic interpolation. The maximum arterial pressure within each R-to-R interval is taken as systolic arterial pressure (SAP). Sequences of 300 values are randomly selected inside each experimental condition. The power spectrum is estimated according to a univariate parametric approach fitting the series to an autoregressive model. Autoregressive spectral density is factorized into components each of them characterized by a central frequency. A spectral component is labeled as LF if its central frequency is between 0.04 and 0.15 Hz, while it is classified as HF if its central frequency is between 0.15 and 0.4 Hz. The HF power of R-to-R series is utilized as a marker of vagal modulation directed to the heart , while the LF power of SAP series is utilized as a marker of sympathetic modulation directed to vessels. The ratio of the LF power to the HF power assessed from R-to-R series is taken as an indicator simpatho-vagal balance directed to the heart. Baroreflex control in the low frequencies is computed as the square root of the ratio of LF(RR) to LF(SAP). Similarly baroreflex control in the high frequencies is defined as the square root of the ratio of HF(RR) to HF(SAP).
The optic nerve sheet's diameter is assessed echographically after induction of general anesthesia and at the end of the surgery.
Management of general anesthesia is standardized:
- induction with propofol 1.5-2 mg/kg, Remifentanil Target Controlled Infusion (TCI) Ce 4 ng/ml , neuromuscolar blockade with cisatracurium 0.2 mg/kg.
- Maintenance: Sevoflurane 0.6-1.5 MAC (State Entropy target: 40-60); Remifentanil TCI (range Ce 3-15 ng/ml) (Surgical Pleth Index target: 20-50).
- mechanical ventilation at respiratory rate ≥14 breats/min, with tidal volume adjusted to maintain end-tidal carbon dioxide at 32-38 mmHg, and Pplateu <32 cmH2O.
Sample size:
to detect a difference in LF/HF ratio of 0.8 with a SD of 1.7, a power of 0.80 and type I error of 0.05, 37 patients are needed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| brachytherapy | – | Other: steep trendelenburg position with pneumoperitoneummales undergoing elective laparoscopic radical prostatectomy steep trendelenburg position with pneumoperitoneum |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Human males undergoing elective laparoscopic prostatectomy
Key inclusion criteria (4 listed)
- males scheduled for elective laparoscopic prostatectomy
- sinus rhythm at ECG
- ectopic heart beats <5% of all heart beats
- american society of anesthesiologists status 1-3
Key exclusion criteria (10 listed)
- autonomic dysfunction (documented or suspected)
- adrenal or thyroid dysfunction
- organ dysfunction secondary to diabetes (i.e. nephropathy, retinopathy, neuropathy)
- history of stroke, traumatic spinal injury, heart surgery or major vascular surgery
- intracranial hypertension (documented or suspected)
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 |
|---|---|---|
| steep trendelenburg position with pneumoperitoneumANS activity and baroreflex modulation is assessed at (i) baseline; (ii) after induction of general anesthesia; (iii) after steep trendelenburg position (head down at 25 degrees); (iv) after induction of pneumoperitoneum and (v) after removal of trendelenburg and pneumoperitoneum | Other | brachytherapy |
Primary outcome
To measure the changes of ANS modulation directed to the heart and to the vessels, and the changes of baroreflex control induced by steep trendelenburg position and pneumoperitoneum
Time frame: Day of surgery
1 secondary outcome
To measure the correlation between ANS changes and hemodynamics
Time frame: day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
- Background: PubMed 18200624Falabella A, Moore-Jeffries E, Sullivan MJ, Nelson R, Lew M. Cardiac function during steep Trendelenburg position and CO2 pneumoperitoneum for robotic-assisted prostatectomy: a trans-oesophageal Doppler probe study. Int J Med Robot. 2007 Dec;3(4):312-5. doi: 10.1002/rcs.165.
- Background: PubMed 19185977Ficarra V, Novara G, Artibani W, Cestari A, Galfano A, Graefen M, Guazzoni G, Guillonneau B, Menon M, Montorsi F, Patel V, Rassweiler J, Van Poppel H. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: a systematic review and cumulative analysis of comparative studies. Eur Urol. 2009 May;55(5):1037-63. doi: 10.1016/j.eururo.2009.01.036. Epub 2009 Jan 25.
- Background: PubMed 19426238Park EY, Koo BN, Min KT, Nam SH. The effect of pneumoperitoneum in the steep Trendelenburg position on cerebral oxygenation. Acta Anaesthesiol Scand. 2009 Aug;53(7):895-9. doi: 10.1111/j.1399-6576.2009.01991.x. Epub 2009 May 6.
- Background: PubMed 19608821Awad H, Santilli S, Ohr M, Roth A, Yan W, Fernandez S, Roth S, Patel V. The effects of steep trendelenburg positioning on intraocular pressure during robotic radical prostatectomy. Anesth Analg. 2009 Aug;109(2):473-8. doi: 10.1213/ane.0b013e3181a9098f.
- Background: PubMed 22944553Amini A, Kariman H, Arhami Dolatabadi A, Hatamabadi HR, Derakhshanfar H, Mansouri B, Safari S, Eqtesadi R. Use of the sonographic diameter of optic nerve sheath to estimate intracranial pressure. Am J Emerg Med. 2013 Jan;31(1):236-9. doi: 10.1016/j.ajem.2012.06.025. Epub 2012 Aug 31.
- Background: PubMed 21233502Lestar M, Gunnarsson L, Lagerstrand L, Wiklund P, Odeberg-Wernerman S. Hemodynamic perturbations during robot-assisted laparoscopic radical prostatectomy in 45 degrees Trendelenburg position. Anesth Analg. 2011 Nov;113(5):1069-75. doi: 10.1213/ANE.0b013e3182075d1f. Epub 2011 Jan 13.
- Background: PubMed 21815239Haas S, Haese A, Goetz AE, Kubitz JC. Haemodynamics and cardiac function during robotic-assisted laparoscopic prostatectomy in steep Trendelenburg position. Int J Med Robot. 2011 Dec;7(4):408-13. doi: 10.1002/rcs.410. Epub 2011 Aug 3.
- Background: PubMed 21965361Crystal GJ, Salem MR. The Bainbridge and the "reverse" Bainbridge reflexes: history, physiology, and clinical relevance. Anesth Analg. 2012 Mar;114(3):520-32. doi: 10.1213/ANE.0b013e3182312e21. Epub 2011 Sep 29.
- Background: PubMed 7923668Montano N, Ruscone TG, Porta A, Lombardi F, Pagani M, Malliani A. Power spectrum analysis of heart rate variability to assess the changes in sympathovagal balance during graded orthostatic tilt. Circulation. 1994 Oct;90(4):1826-31. doi: 10.1161/01.cir.90.4.1826.
- Background: PubMed 2874900Pagani M, Lombardi F, Guzzetti S, Rimoldi O, Furlan R, Pizzinelli P, Sandrone G, Malfatto G, Dell'Orto S, Piccaluga E, et al. Power spectral analysis of heart rate and arterial pressure variabilities as a marker of sympatho-vagal interaction in man and conscious dog. Circ Res. 1986 Aug;59(2):178-93. doi: 10.1161/01.res.59.2.178.
- Background: PubMed 9118511Pagani M, Montano N, Porta A, Malliani A, Abboud FM, Birkett C, Somers VK. Relationship between spectral components of cardiovascular variabilities and direct measures of muscle sympathetic nerve activity in humans. Circulation. 1997 Mar 18;95(6):1441-8. doi: 10.1161/01.cir.95.6.1441.
- Background: PubMed 11045977Ray CA; New Collective Author. Interaction of the vestibular system and baroreflexes on sympathetic nerve activity in humans. Am J Physiol Heart Circ Physiol. 2000 Nov;279(5):H2399-404. doi: 10.1152/ajpheart.2000.279.5.H2399.
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.
Ferdinando Raimondi, Director study chair
Azienda Ospedaliera "L.Sacco"
Riccardo Colombo, Consultant principal investigator
Azienda Ospedaliera "L.Sacco"
Stefano Guzzetti, Director study director
Azienda Ospedaliera "L.Sacco"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervention Affecting Autonomic Nervous System, run by ASST Fatebenefratelli Sacco 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 4 inclusion and 10 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 5 Nov 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To measure the changes of ANS modulation directed to the heart and to the vessels, and the changes of baroreflex control induced by steep trendelenburg position and pneumoperitoneum (time frame: Day of surgery). 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 NCT01927380, which also lists 14 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 5 Nov 2014.