Phantom Limb PainNCT06693427
Effect of Femoral and Sciatic Nerve Blocks, Combined with General Anesthesia, in Postoperative Pain Levels and Phantom Limb Pain Development in Patients Undergoing Lower Limb Amputation
An observational study of Phantom Limb Pain and Amputation, run by DIMITRIOS KATSAROS at 1 site in Greece.
Trial summary
The goal of this observational study is to determine the effect of femoral and sciatic nerve blocks, combined with general anesthesia, in postoperative pain levels and phantom limb pain development in patients undergoing lower limb amputation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Pain, Amputation, Anesthesia, Local
- What is being tested?
- Peripheral Nerve Block
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteGreece
- Study dates
- 1 Nov 2021to 1 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients listed for lower limb amputation 10cm cephalad or 10cm caudal of the knee, due to Peripheral Arterial Disease. All patients presented to the Emergency Department and had completed their surgery in the first 24 hours since presentation. Post-operative follow-up was every 8 hours for the first day, every 12 hours for Day 2-3. Long term follow-up was at 30 days, 3 months, 6 months and 9 months.
Who may be able to join
- Patients undergoing lower limb amputation 10cm cephalad or 10cm caudal of the knee, due to Peripheral Arterial Disease
Who cannot join
- Any form of dementia
- Prior chronic neuropathic pain as assessed with DN4 questionnaire
- Surgery under neuraxial anaesthesia
- Inability to complete a Numeric Rating Scale to assess pain
- Contraindication to ropivacaine
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to determine the effect of femoral and sciatic nerve blocks, combined with general anesthesia, in postoperative pain levels and phantom limb pain development in patients undergoing lower limb amputation.
- Conditions
- Phantom Limb Pain, Amputation, Anesthesia, Local
- Being tested
- Peripheral Nerve Block
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Nerve BlockProcedure or surgery
Femoral and Sciatic Nerve Blocks
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Patients receiving general anesthesia only. | |
| General Anesthesia + Blocks | Patients receiving general anesthesia and peripheral nerve blocks Receives: Procedure: Peripheral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of phantom limb pain
Presence of phantom limp pain and residual limp pain assessed using the Numerical Rating Scale for pain sensation (0-10, 0 being no pain, 10 being the worst imaginable pain)
Measured: Total screening time up to 9 months from day of surgery (DAY 0). Timeframe: DAY 3, DAY 7, DAY 30, DAY 60, DAY 90, DAY 120, DAY 150, DAY 180, DAY 210, DAY 240, DAY 270.
Presence of phantom limb pain
Presence of phantom limp pain and residual limp pain assessed using the Douleur Neuropathique en 4 Questions questionnaire (total scoring 0-10, score of 4 and above indicating presence of neuropathic pain) for neuropathic pain
Measured: Total screening time up to 9 months from day of surgery (DAY 0). Timeframe: DAY 3, DAY 7, DAY 30, DAY 60, DAY 90, DAY 120, DAY 150, DAY 180, DAY 210, DAY 240, DAY 270.
Presence of phantom limb pain
Presence of phantom limp pain and residual limp pain assessed using the painDETECT questionnaire (total scoring 0-38, 0-12 indicating an unlikely component of neuropathic pain, 13-18 an ambiguous result and 19-38 a likely component of neuropathic pain) for neuropathic pain
Measured: Total screening time up to 9 months from day of surgery (DAY 0). Timeframe: DAY 3, DAY 7, DAY 30, DAY 60, DAY 90, DAY 120, DAY 150, DAY 180, DAY 210, DAY 240, DAY 270.
Secondary outcomes (4)
Postoperative morphine consumption
All patients will be connected to an electronic pump for administration of morphine as an analgesic agent through a Patient Controlled Analgesia protocol, which enables the administration of morphine only when required by the patient. At the end of the time frame period the total morphine consumption was measured.
Measured: Up to 3 days after surgery (DAY 0), i. e. until DAY 3
Postoperative pain
Postoperative pain assessed using the Numerical Rating Scale for pain sensation (0-10, 0 being no pain, 10 being the worst imaginable pain)
Measured: Up to 3 days after day of surgery (DAY 0). Assessed at: DAY 0 12 hours after end of surgery, DAY 1 , DAY 2, DAY 3
Postoperative pain
Postoperative pain assessed using the Douleur Neuropathique en 4 Questions questionnaire (total scoring 0-10, score of 4 and above indicating presence of neuropathic pain) for neuropathic pain
Measured: Up to 3 days after day of surgery (DAY 0). Assessed at: DAY 0 12 hours after end of surgery, DAY 1 , DAY 2, DAY 3
Postoperative pain
Postoperative pain assessed using the painDETECT questionnaire (total scoring 0-38, 0-12 indicating an unlikely component of neuropathic pain, 13-18 an ambiguous result and 19-38 a likely component of neuropathic pain) for neuropathic pain
Measured: Up to 3 days after day of surgery (DAY 0). Assessed at: DAY 0 12 hours after end of surgery, DAY 1 , DAY 2, DAY 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Nov 2021
- 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.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Phantom Limb PainStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- DIMITRIOS KATSAROS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DIMITRIOS KATSAROS, G.Gennimatas General Hospital
- Investigators
- Dimitrios Katsaros, Principal investigator, G.Gennimatas General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693427
- Sponsor's protocol ID
- GGennimatasGH 8473
- Status last verified
- Nov 2024
- First submitted
- 24 Jul 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Flor H. Phantom-limb pain: characteristics, causes, and treatment. Lancet Neurol. 2002 Jul;1(3):182-9. doi: 10.1016/s1474-4422(02)00074-1.
PubMed 12849487Laloo R, Ambler GK, Locker D, Twine CP, Bosanquet DC. Systematic Review and Meta-Analysis of the Effect of Perineural Catheters in Major Lower Limb Amputations. Eur J Vasc Endovasc Surg. 2021 Aug;62(2):295-303. doi: 10.1016/j.ejvs.2021.03.008. Epub 2021 Jun 2.
PubMed 34088614Geertzen J, van der Linde H, Rosenbrand K, Conradi M, Deckers J, Koning J, Rietman HS, van der Schaaf D, van der Ploeg R, Schapendonk J, Schrier E, Duijzentkunst RS, Spruit-van Eijk M, Versteegen G, Voesten H. Dutch evidence-based guidelines for amputation and prosthetics of the lower extremity: Rehabilitation process and prosthetics. Part 2. Prosthet Orthot Int. 2015 Oct;39(5):361-71. doi: 10.1177/0309364614542725. Epub 2014 Jul 24.
PubMed 25060393Karanikolas M, Aretha D, Tsolakis I, Monantera G, Kiekkas P, Papadoulas S, Swarm RA, Filos KS. Optimized perioperative analgesia reduces chronic phantom limb pain intensity, prevalence, and frequency: a prospective, randomized, clinical trial. Anesthesiology. 2011 May;114(5):1144-54. doi: 10.1097/ALN.0b013e31820fc7d2.
PubMed 21368651Alviar MJ, Hale T, Dungca M. Pharmacologic interventions for treating phantom limb pain. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD006380. doi: 10.1002/14651858.CD006380.pub2.
PubMed 22161403Tilak M, Isaac SA, Fletcher J, Vasanthan LT, Subbaiah RS, Babu A, Bhide R, Tharion G. Mirror Therapy and Transcutaneous Electrical Nerve Stimulation for Management of Phantom Limb Pain in Amputees - A Single Blinded Randomized Controlled Trial. Physiother Res Int. 2016 Jun;21(2):109-15. doi: 10.1002/pri.1626. Epub 2015 Apr 1.
PubMed 25832306Horlocker TT, Vandermeuelen E, Kopp SL, Gogarten W, Leffert LR, Benzon HT. Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy: American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Fourth Edition). Reg Anesth Pain Med. 2018 Apr;43(3):263-309. doi: 10.1097/AAP.0000000000000763. No abstract available.
PubMed 29561531Natarajan B, Patel P, Mukherjee A. Acute Lower Limb Ischemia-Etiology, Pathology, and Management. Int J Angiol. 2020 Sep;29(3):168-174. doi: 10.1055/s-0040-1713769. Epub 2020 Jun 27.
PubMed 33100802Grant AJ, Wood C. The effect of intra-neural local anaesthetic infusion on pain following major lower limb amputation. Scott Med J. 2008 Feb;53(1):4-6. doi: 10.1258/RSMSMJ.53.1.4.
PubMed 18422201Ayling OG, Montbriand J, Jiang J, Ladak S, Love L, Eisenberg N, Katz J, Clarke H, Roche-Nagle G. Continuous regional anaesthesia provides effective pain management and reduces opioid requirement following major lower limb amputation. Eur J Vasc Endovasc Surg. 2014 Nov;48(5):559-64. doi: 10.1016/j.ejvs.2014.07.002. Epub 2014 Aug 16.
PubMed 25139251von Plato H, Peltoniemi M, Kauhanen P, Loyttyniemi E, Hamunen K, Kontinen V; FinAPain-1 study group. Combination of perineural and wound infusion after above knee amputation: A randomized, controlled multicenter study. Acta Anaesthesiol Scand. 2019 Nov;63(10):1406-1412. doi: 10.1111/aas.13440. Epub 2019 Jul 19.
PubMed 31281981Milosevic S, Strange H, Morgan M, Ambler GK, Bosanquet DC, Waldron CA, Thomas-Jones E, Harris D, Twine CP, Brookes-Howell L. Exploring patients' experiences of analgesia after major lower limb amputation: a qualitative study. BMJ Open. 2021 Dec 1;11(12):e054618. doi: 10.1136/bmjopen-2021-054618.
PubMed 34853109Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.
PubMed 14622683Lambert Aw, Dashfield Ak, Cosgrove C, Wilkins Dc, Walker Aj, Ashley S. Randomized prospective study comparing preoperative epidural and intraoperative perineural analgesia for the prevention of postoperative stump and phantom limb pain following major amputation. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):316-21. doi: 10.1053/rapm.2001.23934.
PubMed 11464349Subedi B, Grossberg GT. Phantom limb pain: mechanisms and treatment approaches. Pain Res Treat. 2011;2011:864605. doi: 10.1155/2011/864605. Epub 2011 Aug 14.
PubMed 22110933
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Femoral and Sciatic Nerve Blocks, Combined with General Anesthesia, in Postoperative Pain Levels and Phantom Limb Pain Development in Patients Undergoing Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT06693427
- Acronym / sponsor ID
- GGennimatasGH 8473
- Conditions
- Phantom Limb Pain, Amputation, Anesthesia, Local
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- DIMITRIOS KATSAROSUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 18 Nov 2024 (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.
The goal of this observational study is to determine the effect of femoral and sciatic nerve blocks, combined with general anesthesia, in postoperative pain levels and phantom limb pain development in patients undergoing lower limb amputation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | – | –Patients receiving general anesthesia only. |
| General Anesthesia + Blocks | – | Procedure: Peripheral Nerve BlockPatients receiving general anesthesia and peripheral nerve blocks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients listed for lower limb amputation 10cm cephalad or 10cm caudal of the knee, due to Peripheral Arterial Disease. All patients presented to the Emergency Department and had completed their surgery in the first 24 hours since presentation. Post-operative follow-up was every 8 hours for the first day, every 12 hours for Day 2-3. Long term follow-up was at 30 days, 3 months, 6 months and 9 months.
Key inclusion criteria (1 listed)
- Patients undergoing lower limb amputation 10cm cephalad or 10cm caudal of the knee, due to Peripheral Arterial Disease
Key exclusion criteria (5 listed)
- Any form of dementia
- Prior chronic neuropathic pain as assessed with DN4 questionnaire
- Surgery under neuraxial anaesthesia
- Inability to complete a Numeric Rating Scale to assess pain
- Contraindication to ropivacaine
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 |
|---|---|---|
| Peripheral Nerve BlockFemoral and Sciatic Nerve Blocks | Procedure or surgery | General Anesthesia + Blocks |
Primary outcome
Presence of phantom limb pain
Time frame: Total screening time up to 9 months from day of surgery (DAY 0). Timeframe: DAY 3, DAY 7, DAY 30, DAY 60, DAY 90, DAY 120, DAY 150, DAY 180, DAY 210, DAY 240, DAY 270.
Presence of phantom limp pain and residual limp pain assessed using the Numerical Rating Scale for pain sensation (0-10, 0 being no pain, 10 being the worst imaginable pain)
Presence of phantom limb pain
Time frame: Total screening time up to 9 months from day of surgery (DAY 0). Timeframe: DAY 3, DAY 7, DAY 30, DAY 60, DAY 90, DAY 120, DAY 150, DAY 180, DAY 210, DAY 240, DAY 270.
Presence of phantom limp pain and residual limp pain assessed using the Douleur Neuropathique en 4 Questions questionnaire (total scoring 0-10, score of 4 and above indicating presence of neuropathic pain) for neuropathic pain
Presence of phantom limb pain
Time frame: Total screening time up to 9 months from day of surgery (DAY 0). Timeframe: DAY 3, DAY 7, DAY 30, DAY 60, DAY 90, DAY 120, DAY 150, DAY 180, DAY 210, DAY 240, DAY 270.
Presence of phantom limp pain and residual limp pain assessed using the painDETECT questionnaire (total scoring 0-38, 0-12 indicating an unlikely component of neuropathic pain, 13-18 an ambiguous result and 19-38 a likely component of neuropathic pain) for neuropathic pain
4 secondary outcomes
Postoperative morphine consumption
Time frame: Up to 3 days after surgery (DAY 0), i. e. until DAY 3
Postoperative pain
Time frame: Up to 3 days after day of surgery (DAY 0). Assessed at: DAY 0 12 hours after end of surgery, DAY 1 , DAY 2, DAY 3
Postoperative pain
Time frame: Up to 3 days after day of surgery (DAY 0). Assessed at: DAY 0 12 hours after end of surgery, DAY 1 , DAY 2, DAY 3
Postoperative pain
Time frame: Up to 3 days after day of surgery (DAY 0). Assessed at: DAY 0 12 hours after end of surgery, DAY 1 , DAY 2, DAY 3
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 18 Nov 2024.
- Background: PubMed 12849487Flor H. Phantom-limb pain: characteristics, causes, and treatment. Lancet Neurol. 2002 Jul;1(3):182-9. doi: 10.1016/s1474-4422(02)00074-1.
- Background: PubMed 34088614Laloo R, Ambler GK, Locker D, Twine CP, Bosanquet DC. Systematic Review and Meta-Analysis of the Effect of Perineural Catheters in Major Lower Limb Amputations. Eur J Vasc Endovasc Surg. 2021 Aug;62(2):295-303. doi: 10.1016/j.ejvs.2021.03.008. Epub 2021 Jun 2.
- Background: PubMed 25060393Geertzen J, van der Linde H, Rosenbrand K, Conradi M, Deckers J, Koning J, Rietman HS, van der Schaaf D, van der Ploeg R, Schapendonk J, Schrier E, Duijzentkunst RS, Spruit-van Eijk M, Versteegen G, Voesten H. Dutch evidence-based guidelines for amputation and prosthetics of the lower extremity: Rehabilitation process and prosthetics. Part 2. Prosthet Orthot Int. 2015 Oct;39(5):361-71. doi: 10.1177/0309364614542725. Epub 2014 Jul 24.
- Background: PubMed 21368651Karanikolas M, Aretha D, Tsolakis I, Monantera G, Kiekkas P, Papadoulas S, Swarm RA, Filos KS. Optimized perioperative analgesia reduces chronic phantom limb pain intensity, prevalence, and frequency: a prospective, randomized, clinical trial. Anesthesiology. 2011 May;114(5):1144-54. doi: 10.1097/ALN.0b013e31820fc7d2.
- Background: PubMed 22161403Alviar MJ, Hale T, Dungca M. Pharmacologic interventions for treating phantom limb pain. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD006380. doi: 10.1002/14651858.CD006380.pub2.
- Background: PubMed 25832306Tilak M, Isaac SA, Fletcher J, Vasanthan LT, Subbaiah RS, Babu A, Bhide R, Tharion G. Mirror Therapy and Transcutaneous Electrical Nerve Stimulation for Management of Phantom Limb Pain in Amputees - A Single Blinded Randomized Controlled Trial. Physiother Res Int. 2016 Jun;21(2):109-15. doi: 10.1002/pri.1626. Epub 2015 Apr 1.
- Background: PubMed 29561531Horlocker TT, Vandermeuelen E, Kopp SL, Gogarten W, Leffert LR, Benzon HT. Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy: American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Fourth Edition). Reg Anesth Pain Med. 2018 Apr;43(3):263-309. doi: 10.1097/AAP.0000000000000763. No abstract available.
- Background: PubMed 33100802Natarajan B, Patel P, Mukherjee A. Acute Lower Limb Ischemia-Etiology, Pathology, and Management. Int J Angiol. 2020 Sep;29(3):168-174. doi: 10.1055/s-0040-1713769. Epub 2020 Jun 27.
- Background: PubMed 18422201Grant AJ, Wood C. The effect of intra-neural local anaesthetic infusion on pain following major lower limb amputation. Scott Med J. 2008 Feb;53(1):4-6. doi: 10.1258/RSMSMJ.53.1.4.
- Background: PubMed 25139251Ayling OG, Montbriand J, Jiang J, Ladak S, Love L, Eisenberg N, Katz J, Clarke H, Roche-Nagle G. Continuous regional anaesthesia provides effective pain management and reduces opioid requirement following major lower limb amputation. Eur J Vasc Endovasc Surg. 2014 Nov;48(5):559-64. doi: 10.1016/j.ejvs.2014.07.002. Epub 2014 Aug 16.
- Background: PubMed 31281981von Plato H, Peltoniemi M, Kauhanen P, Loyttyniemi E, Hamunen K, Kontinen V; FinAPain-1 study group. Combination of perineural and wound infusion after above knee amputation: A randomized, controlled multicenter study. Acta Anaesthesiol Scand. 2019 Nov;63(10):1406-1412. doi: 10.1111/aas.13440. Epub 2019 Jul 19.
- Background: PubMed 34853109Milosevic S, Strange H, Morgan M, Ambler GK, Bosanquet DC, Waldron CA, Thomas-Jones E, Harris D, Twine CP, Brookes-Howell L. Exploring patients' experiences of analgesia after major lower limb amputation: a qualitative study. BMJ Open. 2021 Dec 1;11(12):e054618. doi: 10.1136/bmjopen-2021-054618.
- Individual participant dataSharing planned: Undecided
Related trials for Phantom Limb Pain
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
Recruiting
Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
Lower Limb Amputation
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
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.
Dimitrios Katsaros principal investigator
G.Gennimatas General Hospital
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 Phantom Limb Pain and Amputation, run by DIMITRIOS KATSAROS at 1 site in Greece.
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 1 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: finished, as of the sponsor's last update on 18 Nov 2024. 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 Greece. 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?
Presence of phantom limb pain (time frame: Total screening time up to 9 months from day of surgery (DAY 0). Timeframe: DAY 3, DAY 7, DAY 30, DAY 60, DAY 90, DAY 120, DAY 150, DAY 180, DAY 210, DAY 240, DAY 270.). The study lists 3 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 NCT06693427, which also lists 17 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 18 Nov 2024.