Bariatric Surgery (Sleeve Gastrectomy )NCT06835166
Effect of Intraoperative Position Change on Hemodynamics and Electrocardiography
An observational study of Bariatric Surgery (Sleeve Gastrectomy ) and Hemodynamics, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
The combined effects of obesity-related cardiac structure and function changes, comorbidities, pneumoperitoneum technique, and reverse Trendelenburg position may complicate anesthesia management by affecting intraoperative hemodynamics and cardiac function. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery (Sleeve Gastrectomy ), Hemodynamics, Electrocardiography
- What is being tested?
- 12-lead electrocardiography measurement
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2025to 20 May 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Morbidly obese patients undergoing laparoscopic sleeve gastrectomy
Who may be able to join
- Adult patient planned for elective primary laparoscopic sleeve gastrectomy surgery
- Body Mass Index (BMI) ≥ 40 kg/ / m²
- Age ≥ 18
- ASA physical health class II-III.
Who cannot join
- Patient refusal to participate in the study
- Those who underwent revision laparoscopic sleeve gastrectomy
- Emergency laparoscopic sleeve gastrectomy surgery (stump leakage, etc.)
- Secondary surgery in addition to elective laparoscopic sleeve gastrectomy
- Patients with previous recurrent abdominal surgery
- Patients with electrolyte imbalance
Show all 11Show fewer
- Direct laryngoscopy in ramp position
- Multiple intubation attempts due to difficult intubation
- Preoperative arrhythmia and heart failure (ejection fraction < 30%)
- Renal and liver failure
- Patients who require > 8 ml/kg for tidal volume
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Firat University Hospital, Department of Anesthesiology and Reanimation
Elâzığ, 23200
About this study
Official title: Effect of Intraoperative Position Change on Hemodynamics and Cardiac Electrophysiological Balance Index in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy
The combined effects of obesity-related cardiac structure and function changes, comorbidities, pneumoperitoneum technique, and reverse Trendelenburg position may complicate anesthesia management by affecting intraoperative hemodynamics and cardiac function. Increased intra-abdominal pressure leads to various physiological changes through mechanical and neurohormonal responses. Furthermore, pneumoperitoneum and reverse Trendelenburg position are reported to stimulate the sympathetic nervous system and increase the risk of cardiac arrhythmia.
Obesity-related changes in cardiac structure and function have been shown to predispose to cardiac conduction and repolarization disorders. It has also been stated that obesity directly affects cardiac electrophysiology.
Read more
Moreover, obese patients may have hidden risks associated with the development of cardiac arrhythmias due to the adverse contributions of the cardiovascular effects of anesthesia, pneumoperitoneum, and patient positioning during laparoscopic intervention.
The index of cardiac electrophysiological balance (iCEB) is a non-invasive marker calculated by the QT/QRS ratio that can predict malignant ventricular arrhythmias.
The aim of this study was to investigate the effects of intraoperative patient positions on hemodynamics and the index of cardiac electrophysiological balance (iCEB) during laparoscopic sleeve gastrectomy in morbidly obese patients.
Read the detailed description
Morbidly obese patients who will undergo laparoscopic sleeve gastrectomy will be included in the study.
Patients will be taken to the operating room without premedication after a minimum of 8 hours of fasting. Venous access will be established with a 22 G angiocatheter on the operating table. Routine heart rate, arterial blood pressure, peripheral oxygen saturation (SpO₂), body temperature, bispectral index (BIS) (Bispectral Drager Vista 120 system, Covidien, USA) monitoring will be performed. BIS will be kept between 40 - 60. In addition, 12-lead ECG (Cardioline®) will be used for electrocardiogram (ECG) measurements.
Mechanical ventilation will be provided with a tidal volume of 8 mL/kg (IBW) and a positive end expiratory pressure (PEEP) of 8 cmH₂O. The respiratory rate will be adjusted to maintain end-tidal carbon dioxide (EtCO2) at 35 to 45 mmHg.
Targeted Fluid Management (GDFM) will be provided by continuous Pleth Variability Index (PVI) monitoring by placing a Pulse CO-Oximeter sensor system (Masimo rainbow set® Masimo Corporation, Irvine, CA, USA) on the patients' 4th finger. Hemodynamic targets are both PVI and mean arterial pressure. Fluid loading prescription is based on a PVI value greater than 13%, and vasopressor use is based on a mean arterial pressure < 65 mmHg. If necessary, additional fluids and norepinephrine will be given to maintain mean arterial pressure > 65 mmHg.
A 12-lead ECG will be taken at five intraoperative position measurement points (1. Supine-monitored; 2. After induction; 3. Under general anesthesia-Supine-abdominal inflated; 4. Abdominal inflated-(30% upright) Reverse Trendelenburg; 5. Abdominal deflated-(30% upright) Reverse Trendelenburg). Hemodynamic monitoring [systolic blood pressure (SBP), diastolic blood pressure (DAB), mean arterial pressure (MAP), heart rate (HR)] will be recorded at 5 simultaneous measurement points. All hemodynamic measurements and ECG recordings will be made 3 minutes after the position change to ensure standardization, allow the response to settle after the position change, and prevent the possibility of exaggerated or false data.
All patients will have their surgeries performed by the same surgical team and intra-abdominal pressure will be kept below 15 mmHg.
Demographic data (age, gender, height, weight, BMI), American Society of Anesthesiologists (ASA) physical status classification, preoperative assessment information (comorbidities, medications used), duration of surgery and anesthesia, amount of fluid administered, and amount of norepinephrine to be used when needed will be recorded.
Power analysis was calculated as follows:
Repeated measures, within factors Options: Pillai V, O'Brien-Shieh Algorithm Analysis: A priori: Compute required sample size Input: Effect size f = 0.25 α = 0.05 Power (1-β ) = 0.95 Number of groups = 1 Number of measurements = 5 Corr among rep measures = 0 Output: Noncentrality parameter λ = 20.3125000 Critical F = 2.5226149 Numerator df = 4.0000000 Denominator df = 61.0000000 Total sample size = 65 Actual power = 0.9523977 Pillai V = 0.2380952 Considering that there may be data loss in ECG measurements and evaluations, the number of cases was determined as 80 patients.
Intraoperative hemodynamic and ECG (Heart-electrophysiological balance index (iCEB = QT/QRS ratio) changes in 5 positions will be evaluated.
- Being tested
- 12-lead electrocardiography measurement
- Keywords
- Bariatric Surgery, Laparoscopic sleeve gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-lead electrocardiography measurementProcedure or surgery
Intraoperative 12-lead electrocardiography (EKG) measurement during laparoscopic sleeve gastrectomy in morbidly obese patients:
In all patients, pneumoperitoneum CO₂ intraabdominal pressure will be studied as 15 cmH₂O.
Intraoperatively, 12-lead ECG will be obtained at five position measurement points:
Procedure1. Supine-monitored; Procedure 2. After induction; Procedure 3. Under general anesthesia-Supine-abdominal inflated; Procedure 4. Abdominal inflated-(30% vertical) Reverse Trendelenburg; Procedure 5. Abdominal deflated-(30% vertical) Reverse Trendelenburg.
Hemodynamic monitoring [systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate ] was recorded at 5 simultaneous measurement points.
All hemodynamic measurements and ECG recordings will be performed 3 minutes after the position change to ensure standardization, to allow the response to settle after the position change, and to prevent the possibility of exaggerated-incorrect data.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the QT (ms) interval in morbidly obese patients undergoing laparoscopic sleeve gastrectomy.
Electrocardiograms will be recorded in the following predefined positions:
- Supine - monitored; 2. Post-anesthesia; 3. Under general anesthesia - Supine - abdominal distension; 4. Abdominal distension - (30% vertical) Reverse Trendelenburg; 5. Abdominal distension reduced - (30% vertical) Reverse Trendelenburg)
Measured: The operation takes approximately 2 hours to complete.
Evaluation of QRS (ms) interval in morbidly obese patients undergoing laparoscopic sleeve gastrectomy.
Electrocardiograms will be recorded in the following predefined positions:
(1. Supine - monitored; 2. Post-anesthesia; 3. Under general anesthesia - Supine - abdominal distension; 4. Abdominal distension - (30% vertical) Reverse Trendelenburg; 5. Abdominal distension reduced - (30% vertical) Reverse Trendelenburg)
Measured: The operation takes approximately 2 hours to complete.
Evaluation of the cardiac electrophysiological balance index (QT/QRS) in morbidly obese patients undergoing laparoscopic sleeve gastrectomy.
The QT interval will be measured from the beginning of the QRS complex to the end of the T wave, and the QT/QRS (iCEB) ratio will be calculated.
Measured: The operation takes approximately 2 hours to complete.
Patient height measurement (in meters)
All patients' heights will be measured (in meters).
Measured: Height measurement for each patient takes approximately 10 minutes.
Patients' body weight measurement (kilograms)
Patients' body weights will also be measured (in kilograms).
Measured: Body weight measurement takes approximately 10 minutes for each patient.
Calculation of body mass index (BMI = kg/m²).
Body Mass Index (BMI) is calculated by dividing body weight (kg) by the square of height (m) (BMI = kg/m²).
Measured: This will take approximately 10 minutes for each patient.
Secondary outcomes (2)
Evaluation of patients' blood pressure measurements (mmHg)
Patients' blood pressure will be recorded as systolic, diastolic, and mean blood pressure.
Measurement time points are indicated below:
(1. Supine - monitored; 2. Post-anesthesia; 3. Under general anesthesia - Supine - abdominal distension; 4. Abdominal distension - (30% vertical) Reverse Trendelenburg; 5. Abdominal distension reduced - (30% vertical) Reverse Trendelenburg)
Measured: The operation takes approximately 2 hours to complete.
measurement of patients' heart rates (beats/min)
Measurement time points are indicated below:
(1. Supine - monitored; 2. Post-anesthesia; 3. Under general anesthesia - Supine - abdominal distension; 4. Abdominal distension - (30% vertical) Reverse Trendelenburg; 5. Abdominal distension reduced - (30% vertical) Reverse Trendelenburg)
Measured: The operation takes approximately 2 hours to complete.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start10 Feb 2025
- Primary completion25 Apr 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery (Sleeve Gastrectomy )Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Çelik, Firat University
- Investigators
- Fatma Çelik, Assoc. Dr., Principal investigator, fatma.celik@firat.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835166
- Sponsor's protocol ID
- FiratU-ANEST-FC-01
- Status last verified
- Jan 2026
- First submitted
- 6 Feb 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not yet decided whether to share the IPDs of our study.
Publications
Atkinson TM, Giraud GD, Togioka BM, Jones DB, Cigarroa JE. Cardiovascular and Ventilatory Consequences of Laparoscopic Surgery. Circulation. 2017 Feb 14;135(7):700-710. doi: 10.1161/CIRCULATIONAHA.116.023262.
PubMed 28193800
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Position Change on Hemodynamics and Cardiac Electrophysiological Balance Index in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT06835166
- Acronym / sponsor ID
- FiratU-ANEST-FC-01
- Keywords
- Bariatric Surgery, Laparoscopic sleeve gastrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 19 Feb 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 combined effects of obesity-related cardiac structure and function changes, comorbidities, pneumoperitoneum technique, and reverse Trendelenburg position may complicate anesthesia management by affecting intraoperative hemodynamics and cardiac function. Increased intra-abdominal pressure leads to various physiological changes through mechanical and neurohormonal responses. Furthermore, pneumoperitoneum and reverse Trendelenburg position are reported to stimulate the sympathetic nervous system and increase the risk of cardiac arrhythmia.
Obesity-related changes in cardiac structure and function have been shown to predispose to cardiac conduction and repolarization disorders. It has also been stated that obesity directly affects cardiac electrophysiology.
Moreover, obese patients may have hidden risks associated with the development of cardiac arrhythmias due to the adverse contributions of the cardiovascular effects of anesthesia, pneumoperitoneum, and patient positioning during laparoscopic intervention.
The index of cardiac electrophysiological balance (iCEB) is a non-invasive marker calculated by the QT/QRS ratio that can predict malignant ventricular arrhythmias.
The aim of this study was to investigate the effects of intraoperative patient positions on hemodynamics and the index of cardiac electrophysiological balance (iCEB) during laparoscopic sleeve gastrectomy in morbidly obese patients.
Detailed description
Morbidly obese patients who will undergo laparoscopic sleeve gastrectomy will be included in the study.
Patients will be taken to the operating room without premedication after a minimum of 8 hours of fasting. Venous access will be established with a 22 G angiocatheter on the operating table. Routine heart rate, arterial blood pressure, peripheral oxygen saturation (SpO₂), body temperature, bispectral index (BIS) (Bispectral Drager Vista 120 system, Covidien, USA) monitoring will be performed. BIS will be kept between 40 - 60. In addition, 12-lead ECG (Cardioline®) will be used for electrocardiogram (ECG) measurements.
Mechanical ventilation will be provided with a tidal volume of 8 mL/kg (IBW) and a positive end expiratory pressure (PEEP) of 8 cmH₂O. The respiratory rate will be adjusted to maintain end-tidal carbon dioxide (EtCO2) at 35 to 45 mmHg.
Targeted Fluid Management (GDFM) will be provided by continuous Pleth Variability Index (PVI) monitoring by placing a Pulse CO-Oximeter sensor system (Masimo rainbow set® Masimo Corporation, Irvine, CA, USA) on the patients' 4th finger. Hemodynamic targets are both PVI and mean arterial pressure. Fluid loading prescription is based on a PVI value greater than 13%, and vasopressor use is based on a mean arterial pressure < 65 mmHg. If necessary, additional fluids and norepinephrine will be given to maintain mean arterial pressure > 65 mmHg.
A 12-lead ECG will be taken at five intraoperative position measurement points (1. Supine-monitored; 2. After induction; 3. Under general anesthesia-Supine-abdominal inflated; 4. Abdominal inflated-(30% upright) Reverse Trendelenburg; 5. Abdominal deflated-(30% upright) Reverse Trendelenburg). Hemodynamic monitoring [systolic blood pressure (SBP), diastolic blood pressure (DAB), mean arterial pressure (MAP), heart rate (HR)] will be recorded at 5 simultaneous measurement points. All hemodynamic measurements and ECG recordings will be made 3 minutes after the position change to ensure standardization, allow the response to settle after the position change, and prevent the possibility of exaggerated or false data.
All patients will have their surgeries performed by the same surgical team and intra-abdominal pressure will be kept below 15 mmHg.
Demographic data (age, gender, height, weight, BMI), American Society of Anesthesiologists (ASA) physical status classification, preoperative assessment information (comorbidities, medications used), duration of surgery and anesthesia, amount of fluid administered, and amount of norepinephrine to be used when needed will be recorded.
Power analysis was calculated as follows:
Repeated measures, within factors Options: Pillai V, O'Brien-Shieh Algorithm Analysis: A priori: Compute required sample size Input: Effect size f = 0.25 α = 0.05 Power (1-β ) = 0.95 Number of groups = 1 Number of measurements = 5 Corr among rep measures = 0 Output: Noncentrality parameter λ = 20.3125000 Critical F = 2.5226149 Numerator df = 4.0000000 Denominator df = 61.0000000 Total sample size = 65 Actual power = 0.9523977 Pillai V = 0.2380952 Considering that there may be data loss in ECG measurements and evaluations, the number of cases was determined as 80 patients.
Intraoperative hemodynamic and ECG (Heart-electrophysiological balance index (iCEB = QT/QRS ratio) changes in 5 positions will be evaluated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Morbidly obese patients undergoing laparoscopic sleeve gastrectomy
Key inclusion criteria (4 listed)
- Adult patient planned for elective primary laparoscopic sleeve gastrectomy surgery
- Body Mass Index (BMI) ≥ 40 kg/ / m²
- Age ≥ 18
- ASA physical health class II-III.
Key exclusion criteria (11 listed)
- Patient refusal to participate in the study
- Those who underwent revision laparoscopic sleeve gastrectomy
- Emergency laparoscopic sleeve gastrectomy surgery (stump leakage, etc.)
- Secondary surgery in addition to elective laparoscopic sleeve gastrectomy
- Patients with previous recurrent abdominal surgery
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 |
|---|---|---|
| 12-lead electrocardiography measurementIntraoperative 12-lead electrocardiography (EKG) measurement during laparoscopic sleeve gastrectomy in morbidly obese patients: In all patients, pneumoperitoneum CO₂ intraabdominal pressure will be studied as 15 cmH₂O. Intraoperatively, 12-lead ECG will be obtained at five position measurement points: Procedure1. Supine-monitored; Procedure 2. After induction; Procedure 3. Under general anesthesia-Supine-abdominal inflated; Procedure 4. Abdominal inflated-(30% vertical) Reverse Trendelenburg; Procedure 5. Abdominal deflated-(30% vertical) Reverse Trendelenburg. Hemodynamic monitoring [systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate ] was recorded at 5 simultaneous measurement points. All hemodynamic measurements and ECG recordings will be performed 3 minutes after the position change to ensure standardization, to allow the response to settle after the position change, and to prevent the possibility of exaggerated-incorrect data. | Procedure or surgery | – |
Primary outcome
Evaluation of the QT (ms) interval in morbidly obese patients undergoing laparoscopic sleeve gastrectomy.
Time frame: The operation takes approximately 2 hours to complete.
Electrocardiograms will be recorded in the following predefined positions: 1. Supine - monitored; 2. Post-anesthesia; 3. Under general anesthesia - Supine - abdominal distension; 4. Abdominal distension - (30% vertical) Reverse Trendelenburg; 5. Abdominal distension reduced - (30% vertical) Reverse Trendelenburg)
Evaluation of QRS (ms) interval in morbidly obese patients undergoing laparoscopic sleeve gastrectomy.
Time frame: The operation takes approximately 2 hours to complete.
Electrocardiograms will be recorded in the following predefined positions: (1. Supine - monitored; 2. Post-anesthesia; 3. Under general anesthesia - Supine - abdominal distension; 4. Abdominal distension - (30% vertical) Reverse Trendelenburg; 5. Abdominal distension reduced - (30% vertical) Reverse Trendelenburg)
Evaluation of the cardiac electrophysiological balance index (QT/QRS) in morbidly obese patients undergoing laparoscopic sleeve gastrectomy.
Time frame: The operation takes approximately 2 hours to complete.
The QT interval will be measured from the beginning of the QRS complex to the end of the T wave, and the QT/QRS (iCEB) ratio will be calculated.
Patient height measurement (in meters)
Time frame: Height measurement for each patient takes approximately 10 minutes.
All patients' heights will be measured (in meters).
Patients' body weight measurement (kilograms)
Time frame: Body weight measurement takes approximately 10 minutes for each patient.
Patients' body weights will also be measured (in kilograms).
Calculation of body mass index (BMI = kg/m²).
Time frame: This will take approximately 10 minutes for each patient.
Body Mass Index (BMI) is calculated by dividing body weight (kg) by the square of height (m) (BMI = kg/m²).
2 secondary outcomes
Evaluation of patients' blood pressure measurements (mmHg)
Time frame: The operation takes approximately 2 hours to complete.
measurement of patients' heart rates (beats/min)
Time frame: The operation takes approximately 2 hours to complete.
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 16 Jan 2026.
- Background: PubMed 28193800Atkinson TM, Giraud GD, Togioka BM, Jones DB, Cigarroa JE. Cardiovascular and Ventilatory Consequences of Laparoscopic Surgery. Circulation. 2017 Feb 14;135(7):700-710. doi: 10.1161/CIRCULATIONAHA.116.023262.
- Echocardiographic and hemodynamic evaluation of cardiovascular performance during laparoscopy of morbidly obese patientsLink provided by the sponsor.
- Evaluation of index of cardio-electrophysiological balance in patients with coronary slow flowLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We have not yet decided whether to share the IPDs of our study.
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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.
Fatma Çelik, Assoc. Dr. principal investigator
fatma.celik@firat.edu.tr
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 Bariatric Surgery (Sleeve Gastrectomy ) and Hemodynamics, run by Firat University at 1 site in Turkey (Türkiye).
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 11 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 16 Jan 2026. 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 Turkey (Türkiye). 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?
Evaluation of the QT (ms) interval in morbidly obese patients undergoing laparoscopic sleeve gastrectomy. (time frame: The operation takes approximately 2 hours to complete.). 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 NCT06835166, which also lists 1 linked publication.
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 16 Jan 2026.