Intra-aortic Balloon PumpNCT06947174
The Role of Angiographic Measurements and Anatomical Correlations in Intra-Aortic Balloon Pump (IABP) Size Selection
An observational study of Intra-aortic Balloon Pump, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
The goal of this study aim to accurately size the IABP size for patients. The main questions it aims to answer are: Are patients's height, jugular notch to transpyloric plane distance and distance from the carina to the upper part of the first lumbar vertebra (measured by chest X-ray) are a good surrogate for IABP… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intra-aortic Balloon Pump
- How many people
- 68 participants
- Where
- 1 siteThailand
- Study dates
- 25 Jan 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing transfemoral angiography at Siriraj cauterization lab.
Who may be able to join
- Patients had obtained CT scan of chest with upper abdomen with celiac trunk visualize within 1 year from the day of transfemoral angiography
- Patients had who will undergo transfemoral angiography as clinical indicated
- Patients had obtained Chest X-ray within 1 year from the day of transfemoral angiography
Who cannot join
- Patient with limb amputation
- Patient with known aortic abnormalities such as aortic aneurysm, aortic dissection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok Noi, Bangkok, 10700
James Tisyakorn, Doctor of Medicine, +66925549747, james51236@gmail.com
Ploy Pengchata, Doctor of Medicine, +66894500223, ploypeng097@gmail.com
About this study
The goal of this study aim to accurately size the IABP size for patients. The main questions it aims to answer are:
- Are patients's height, jugular notch to transpyloric plane distance and distance from the carina to the upper part of the first lumbar vertebra (measured by chest X-ray) are a good surrogate for IABP sizing?
- Is the distance obtained during a transfemoral artery catheterization a reliable way to size the IABP? Researchers will enroll patient who have had previous CT that include thoracic aorta to celiac trunk who will undergo transfemoral angiography.
- All patients that researcher enrolled will undergo transfemoral angiography, during which the researchers will measure the vessel distance using a wire after the procedure end.
- Researchers will measure the height weight, jugular notch to transpyloric plane distance, CXR distance from carina to upper border of L1 and the distance from aorta at subclavian level to celiac trunk from CT.
- Researchers will find the correlation between of each measurement to the distance from aorta at subclavian level to celiac trunk from CT (considered the standard measure).
Read the detailed description
Background:
- Intra-aortic balloon pumps (IABP) are commonly used as mechanical circulatory support in patient with cariogenic shock.
- Proper sizing of IABP is critical, critical, with the balloon typically extending from the left subclavian artery to the celiac axis, and occupying 90-95% of the aorta's diameter during each cycle.
- Manufacturers usually recommend balloon sizes based on patient height. However, previous studies suggest that the accuracy of these recommendations varies. One study found that while chest X-ray (CXR) confirmed correct balloon positioning in 96.8% of cases, only 38.1% were accurately positioned based on CT scans.
- Malposition of the balloon, such as blocking the renal or mesenteric arteries, may lead to complications like renal or intra-abdominal ischemia
- Cadaveric studies have suggested that the distance from the jugular notch to the transpyloric plane correlates more strongly with the subclavian-to-celiac artery distance than height alone
- A Chinese study attempted to predict the left subclavian artery to celiac trunk distance using a combination of height, body mass index (BMI), and age
- In this study, investigators want to find the better way in sizing IABP balloon. Investigators with use the height, age, weight, jugular notch to transpyloric plane distance, distance from the carina to the upper part of the first lumbar vertebra (measured by chest X-ray) and length of the vessel measured during transfemoral angiography compare with distance of the vessel measure during CT-scan.
Outcome
- Investigators will find the correlation between height, jugular notch to transpyloric plane distance, wire pull out distance from aortic knob to L1 in angiographic study and distance of left subclavian artery to celiac trunk measure from CT aorta using Pearson Correlation or Spearman rank statistics.
- Referencing previous studies
The correlation coefficient between height and the distance to the LCA-celiac trunk was 0.369 , and the correlation coefficient between height and the distance to the LCA-renal artery was 0.579 (Igari T. The length of the aorta from the subclavian artery to the renal artery based on computed tomographic measurements in Japanese adults. Journal of Artificial Organs. 2006;9:267-70.). The researcher chose to use the lower correlation coefficient of 0.369 for calculating sample size to achieve a maximum sample size.Using the formula for calculating sample size for correlation coefficient testing, with a standard value of 1.96 set at a significance level of 5% and a power of 80%, the sample size was calculated as follows:
- Fisher's Z Transformation from formula = = 1/2 ln((1+(0.369))/(1-(0.369)))= 0.387 Calculate sample size by n= ((1.96+0.84)/(0.387))^2+3 n = 56 Sample size from this calculation is 56, it was determined that an additional sample size of 56 participants is needed, with a further increase of 20% to account for potential data loss, resulting in an additional 12 participants, totaling 68 individuals. Therefore, the sample size used in this study is 68 participants Recruitments - Investigators will review patients scheduled for angiography to determine if they have had a CT chest scan that includes the celiac trunk and are eligible for the study.
Inclusion criteria are
- Patient age ≥ 18 years old
- Patients had obtained CT scan of chest with upper abdomen with celiac trunk visualize within 1 year from the day of transfemoral angiography
- Patients had who will undergo transfemoral angiography as clinical indicated
- Patients had obtained Chest X-ray within 1 year from the day of transfemoral angiography Exclusion criteria are
- Patient with limb amputation 2. Patient with known aortic abnormalities such as aortic aneurysm, aortic dissection Study procedure
- Before the patient's arrival at the catheterization lab, the investigator will seek their consent to participate in the study.
- Patients will be informed that their treatment will proceed as usual, with the only additional step being a request for the procedure operator to measure the pullback wire distance at the end of the procedure. This step will result in slightly more radiation exposure but will take less than one minute to complete and does not increase the procedural risk.
- If the operator determines that the patient is unstable, the measurement will not be performed. Patients who choose not to participate will still receive their standard treatment without any changes.
- Other measurements such as height weight will be collected per Cath lab protocol.
- The measurement of jugular notch to transpyloric plane distance will be collect at the recovery ward.
- Conditions
- Intra-aortic Balloon Pump
- Keywords
- Intra-aortic balloon pump
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
Height of the patients
Measured: Day 1
Weight
Weight of the patient
Measured: Day 1
Jugular notch to transpyloric plane distance
Distance from jugular notch to transpyloric plane (Horizontal plane between jugular notch to pubic symphysis)
Measured: Day 1
distance from the carina to the upper part of the first lumbar vertebra (measured by chest X-ray)
distance from the carina to the upper part of the first lumbar vertebra (measured by chest X-ray)
Measured: through study completion, an average of 1 year
distance of left subclavian artery to celiac trunk measure from CT scan.
distance of left subclavian artery to celiac trunk measure from CT scan.
Measured: through study completion, an average of 1 year
distance from the carina to the upper part of the first lumbar vertebra measure by wiring distance during transferal angiography
Wiring distance is obtained during the transferal angiography after the procedure is done and when the operator take the wire out. Mesure at the carina level to the upper part of the first lumbar vertebra
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start25 Jan 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Intra-aortic Balloon PumpStudies 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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Tisyakorn, Siriraj Hospital
- Investigators
- Ploy Pengchata, Doctor of Medicine, Principal investigator, Her Majesty Cardiac Center, Faculty of Medicine Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947174
- Sponsor's protocol ID
- 928/2567(IRB4)
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Yang IY, Oraee S, Viejo C, Stern H. Computed tomography celiac trunk topography relating to celiac plexus block. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):21-5. doi: 10.1097/AAP.0b013e318203067f.
PubMed 21455084Kim JT, Lee JR, Kim JK, Yoon SZ, Jeon Y, Bahk JH, Kim KB, Kim CS, Lim YJ, Kim HS, Kim SD. The carina as a useful radiographic landmark for positioning the intraaortic balloon pump. Anesth Analg. 2007 Sep;105(3):735-8. doi: 10.1213/01.ane.0000278086.23266.35.
PubMed 17717232Chaturvedi A, Rotman Y, Hoang T, Jew G, Mandalapu A, Narins C. CT and chest radiography in evaluation of mechanical circulatory support devices for acute heart failure. Insights Imaging. 2023 Jul 16;14(1):122. doi: 10.1186/s13244-023-01469-8.
PubMed 37454301Rhodes NG, Johnson TF, Boyum JH, Khandelwal A, Howell BD, Froemming AT, Behfar A. Radiology of Intra-Aortic Balloon Pump Catheters. Radiol Cardiothorac Imaging. 2022 Apr 14;4(2):e210120. doi: 10.1148/ryct.210120. eCollection 2022 Apr.
PubMed 35506140Parissis H, Soo A, Leotsinidis M, Dougenis D. A statistical model that predicts the length from the left subclavian artery to the celiac axis; towards accurate intra aortic balloon sizing. J Cardiothorac Surg. 2011 Aug 9;6:95. doi: 10.1186/1749-8090-6-95.
PubMed 21827666Byon HJ, Kim H, Kim HC, Kim JT, Kim HS, Lee SC, Kim CS. Potential risk for intra-aortic balloon-induced obstruction to the celiac axis or the renal artery in the Asian population. Thorac Cardiovasc Surg. 2011 Mar;59(2):99-102. doi: 10.1055/s-0030-1250429. Epub 2011 Mar 7.
PubMed 21384305Igari T. The length of the aorta from the subclavian artery to the renal artery based on computed tomographic measurements in Japanese adults. J Artif Organs. 2006;9(4):267-70. doi: 10.1007/s10047-006-0346-z. Epub 2006 Dec 21.
PubMed 17171407Shin H, Yozu R, Sumida T, Kawada S. Acute ischemic hepatic failure resulting from intraaortic balloon pump malposition. Eur J Cardiothorac Surg. 2000 Apr;17(4):492-4. doi: 10.1016/s1010-7940(00)00366-3.
PubMed 10773577Swartz MT, Sakamoto T, Arai H, Reedy JE, Salenas L, Yuda T, Standeven JW, Pennington DG. Effects of intraaortic balloon position on renal artery blood flow. Ann Thorac Surg. 1992 Apr;53(4):604-10. doi: 10.1016/0003-4975(92)90318-x.
PubMed 1554268Rastan AJ, Tillmann E, Subramanian S, Lehmkuhl L, Funkat AK, Leontyev S, Doenst T, Walther T, Gutberlet M, Mohr FW. Visceral arterial compromise during intra-aortic balloon counterpulsation therapy. Circulation. 2010 Sep 14;122(11 Suppl):S92-9. doi: 10.1161/CIRCULATIONAHA.109.929810.
PubMed 20837932Weber KT, Janicki JS. Intraaortic balloon counterpulsation. A review of physiological principles, clinical results, and device safety. Ann Thorac Surg. 1974 Jun;17(6):602-36. doi: 10.1016/s0003-4975(10)65706-2. No abstract available.
PubMed 4601521
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Angiographic Measurements and Anatomical Correlations in Intra-Aortic Balloon Pump (IABP) Size Selection
- ClinicalTrials.gov ID
- NCT06947174
- Acronym / sponsor ID
- 928/2567(IRB4)
- Conditions
- Intra-aortic Balloon Pump
- Keywords
- Intra-aortic balloon pump
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Apr 2025 (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 study aim to accurately size the IABP size for patients. The main questions it aims to answer are:
- Are patients's height, jugular notch to transpyloric plane distance and distance from the carina to the upper part of the first lumbar vertebra (measured by chest X-ray) are a good surrogate for IABP sizing?
- Is the distance obtained during a transfemoral artery catheterization a reliable way to size the IABP? Researchers will enroll patient who have had previous CT that include thoracic aorta to celiac trunk who will undergo transfemoral angiography.
- All patients that researcher enrolled will undergo transfemoral angiography, during which the researchers will measure the vessel distance using a wire after the procedure end.
- Researchers will measure the height weight, jugular notch to transpyloric plane distance, CXR distance from carina to upper border of L1 and the distance from aorta at subclavian level to celiac trunk from CT.
- Researchers will find the correlation between of each measurement to the distance from aorta at subclavian level to celiac trunk from CT (considered the standard measure).
Detailed description
Background:
- Intra-aortic balloon pumps (IABP) are commonly used as mechanical circulatory support in patient with cariogenic shock.
- Proper sizing of IABP is critical, critical, with the balloon typically extending from the left subclavian artery to the celiac axis, and occupying 90-95% of the aorta's diameter during each cycle.
- Manufacturers usually recommend balloon sizes based on patient height. However, previous studies suggest that the accuracy of these recommendations varies. One study found that while chest X-ray (CXR) confirmed correct balloon positioning in 96.8% of cases, only 38.1% were accurately positioned based on CT scans.
- Malposition of the balloon, such as blocking the renal or mesenteric arteries, may lead to complications like renal or intra-abdominal ischemia
- Cadaveric studies have suggested that the distance from the jugular notch to the transpyloric plane correlates more strongly with the subclavian-to-celiac artery distance than height alone
- A Chinese study attempted to predict the left subclavian artery to celiac trunk distance using a combination of height, body mass index (BMI), and age
- In this study, investigators want to find the better way in sizing IABP balloon. Investigators with use the height, age, weight, jugular notch to transpyloric plane distance, distance from the carina to the upper part of the first lumbar vertebra (measured by chest X-ray) and length of the vessel measured during transfemoral angiography compare with distance of the vessel measure during CT-scan.
Outcome
- Investigators will find the correlation between height, jugular notch to transpyloric plane distance, wire pull out distance from aortic knob to L1 in angiographic study and distance of left subclavian artery to celiac trunk measure from CT aorta using Pearson Correlation or Spearman rank statistics.
- Referencing previous studies
The correlation coefficient between height and the distance to the LCA-celiac trunk was 0.369 , and the correlation coefficient between height and the distance to the LCA-renal artery was 0.579 (Igari T. The length of the aorta from the subclavian artery to the renal artery based on computed tomographic measurements in Japanese adults. Journal of Artificial Organs. 2006;9:267-70.). The researcher chose to use the lower correlation coefficient of 0.369 for calculating sample size to achieve a maximum sample size.Using the formula for calculating sample size for correlation coefficient testing, with a standard value of 1.96 set at a significance level of 5% and a power of 80%, the sample size was calculated as follows:
- Fisher's Z Transformation from formula = = 1/2 ln((1+(0.369))/(1-(0.369)))= 0.387 Calculate sample size by n= ((1.96+0.84)/(0.387))^2+3 n = 56 Sample size from this calculation is 56, it was determined that an additional sample size of 56 participants is needed, with a further increase of 20% to account for potential data loss, resulting in an additional 12 participants, totaling 68 individuals. Therefore, the sample size used in this study is 68 participants Recruitments - Investigators will review patients scheduled for angiography to determine if they have had a CT chest scan that includes the celiac trunk and are eligible for the study.
Inclusion criteria are
- Patient age ≥ 18 years old
- Patients had obtained CT scan of chest with upper abdomen with celiac trunk visualize within 1 year from the day of transfemoral angiography
- Patients had who will undergo transfemoral angiography as clinical indicated
- Patients had obtained Chest X-ray within 1 year from the day of transfemoral angiography Exclusion criteria are
- Patient with limb amputation 2. Patient with known aortic abnormalities such as aortic aneurysm, aortic dissection Study procedure
- Before the patient's arrival at the catheterization lab, the investigator will seek their consent to participate in the study.
- Patients will be informed that their treatment will proceed as usual, with the only additional step being a request for the procedure operator to measure the pullback wire distance at the end of the procedure. This step will result in slightly more radiation exposure but will take less than one minute to complete and does not increase the procedural risk.
- If the operator determines that the patient is unstable, the measurement will not be performed. Patients who choose not to participate will still receive their standard treatment without any changes.
- Other measurements such as height weight will be collected per Cath lab protocol.
- The measurement of jugular notch to transpyloric plane distance will be collect at the recovery ward.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing transfemoral angiography at Siriraj cauterization lab.
Key inclusion criteria (3 listed)
- Patients had obtained CT scan of chest with upper abdomen with celiac trunk visualize within 1 year from the day of transfemoral angiography
- Patients had who will undergo transfemoral angiography as clinical indicated
- Patients had obtained Chest X-ray within 1 year from the day of transfemoral angiography
Key exclusion criteria (2 listed)
- Patient with limb amputation
- Patient with known aortic abnormalities such as aortic aneurysm, aortic dissection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Height
Time frame: Day 1
Height of the patients
Weight
Time frame: Day 1
Weight of the patient
Jugular notch to transpyloric plane distance
Time frame: Day 1
Distance from jugular notch to transpyloric plane (Horizontal plane between jugular notch to pubic symphysis)
distance from the carina to the upper part of the first lumbar vertebra (measured by chest X-ray)
Time frame: through study completion, an average of 1 year
distance from the carina to the upper part of the first lumbar vertebra (measured by chest X-ray)
distance of left subclavian artery to celiac trunk measure from CT scan.
Time frame: through study completion, an average of 1 year
distance of left subclavian artery to celiac trunk measure from CT scan.
distance from the carina to the upper part of the first lumbar vertebra measure by wiring distance during transferal angiography
Time frame: Day 1
Wiring distance is obtained during the transferal angiography after the procedure is done and when the operator take the wire out. Mesure at the carina level to the upper part of the first lumbar vertebra
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Results publication: PubMed 21455084Yang IY, Oraee S, Viejo C, Stern H. Computed tomography celiac trunk topography relating to celiac plexus block. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):21-5. doi: 10.1097/AAP.0b013e318203067f.
- Results publication: PubMed 17717232Kim JT, Lee JR, Kim JK, Yoon SZ, Jeon Y, Bahk JH, Kim KB, Kim CS, Lim YJ, Kim HS, Kim SD. The carina as a useful radiographic landmark for positioning the intraaortic balloon pump. Anesth Analg. 2007 Sep;105(3):735-8. doi: 10.1213/01.ane.0000278086.23266.35.
- Results publication: PubMed 37454301Chaturvedi A, Rotman Y, Hoang T, Jew G, Mandalapu A, Narins C. CT and chest radiography in evaluation of mechanical circulatory support devices for acute heart failure. Insights Imaging. 2023 Jul 16;14(1):122. doi: 10.1186/s13244-023-01469-8.
- Results publication: PubMed 35506140Rhodes NG, Johnson TF, Boyum JH, Khandelwal A, Howell BD, Froemming AT, Behfar A. Radiology of Intra-Aortic Balloon Pump Catheters. Radiol Cardiothorac Imaging. 2022 Apr 14;4(2):e210120. doi: 10.1148/ryct.210120. eCollection 2022 Apr.
- Results publication: PubMed 21827666Parissis H, Soo A, Leotsinidis M, Dougenis D. A statistical model that predicts the length from the left subclavian artery to the celiac axis; towards accurate intra aortic balloon sizing. J Cardiothorac Surg. 2011 Aug 9;6:95. doi: 10.1186/1749-8090-6-95.
- Results publication: PubMed 21384305Byon HJ, Kim H, Kim HC, Kim JT, Kim HS, Lee SC, Kim CS. Potential risk for intra-aortic balloon-induced obstruction to the celiac axis or the renal artery in the Asian population. Thorac Cardiovasc Surg. 2011 Mar;59(2):99-102. doi: 10.1055/s-0030-1250429. Epub 2011 Mar 7.
- Results publication: PubMed 17171407Igari T. The length of the aorta from the subclavian artery to the renal artery based on computed tomographic measurements in Japanese adults. J Artif Organs. 2006;9(4):267-70. doi: 10.1007/s10047-006-0346-z. Epub 2006 Dec 21.
- Results publication: PubMed 10773577Shin H, Yozu R, Sumida T, Kawada S. Acute ischemic hepatic failure resulting from intraaortic balloon pump malposition. Eur J Cardiothorac Surg. 2000 Apr;17(4):492-4. doi: 10.1016/s1010-7940(00)00366-3.
- Results publication: PubMed 1554268Swartz MT, Sakamoto T, Arai H, Reedy JE, Salenas L, Yuda T, Standeven JW, Pennington DG. Effects of intraaortic balloon position on renal artery blood flow. Ann Thorac Surg. 1992 Apr;53(4):604-10. doi: 10.1016/0003-4975(92)90318-x.
- Results publication: PubMed 20837932Rastan AJ, Tillmann E, Subramanian S, Lehmkuhl L, Funkat AK, Leontyev S, Doenst T, Walther T, Gutberlet M, Mohr FW. Visceral arterial compromise during intra-aortic balloon counterpulsation therapy. Circulation. 2010 Sep 14;122(11 Suppl):S92-9. doi: 10.1161/CIRCULATIONAHA.109.929810.
- Results publication: PubMed 4601521Weber KT, Janicki JS. Intraaortic balloon counterpulsation. A review of physiological principles, clinical results, and device safety. Ann Thorac Surg. 1974 Jun;17(6):602-36. doi: 10.1016/s0003-4975(10)65706-2. No abstract available.
- Individual participant dataSharing planned: Yes
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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.
Ploy Pengchata, Doctor of Medicine principal investigator
Her Majesty Cardiac Center, Faculty of Medicine Siriraj 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 Intra-aortic Balloon Pump, run by Siriraj Hospital at 1 site in Thailand.
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 2 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: looking for participants now, as of the sponsor's last update on 27 Apr 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Tisyakorn, Doctor of Medicine (+66925549747, james51236@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height (time frame: Day 1). The study lists 6 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 NCT06947174, which also lists 11 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 27 Apr 2025.