Obese Patients (BMI ≥ 30 kg/m²)NCT07070908
Modifications to Gastric Sleeve: Implications for GRED and Quality of Life
A study testing Antrum calibration, Fudus calibration and No antrum calibration in people with Obese Patients (BMI ≥ 30 kg/m²) and Obese Patients, run by Hospital San Juan de Dios Tenerife at 1 site in Spain.
Trial summary
This is a prospective randomized clinical trial evaluating the impact of antrum and fundus calibration during laparoscopic vertical gastrectomy (VG) on postoperative gastroesophageal reflux disease (GERD), quality of life, and surgical costs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obese Patients (BMI ≥ 30 kg/m²), Obese Patients, Obese Patients With Bariatric Surgery
- What is being tested?
- Antrum calibration, Fudus calibration and No antrum calibration
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 6 Apr 2020to 31 Dec 2025
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with morbid obesity on the waiting list for bariatric surgery.
- Both male and female participants.
- Age between 18 and 65 years.
- BMI > 35 kg/m².
- Availability to attend scheduled follow-up visits.
- Indication for sleeve gastrectomy as the first bariatric procedure.
Who cannot join
- Obesity of endocrine origin.
- Preoperative GERD (diagnosed by pH-metry or upper endoscopy following a positive GERD-HRQL test).
- Active gastrointestinal disease (such as esophagitis, peptic ulcer, cancer, or esophageal motility disorder), diagnosed by endoscopy or manometry.
- History of previous gastric surgery.
- Patients not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modifications to Gastric Tube Construction in Vertical Gastrectomy: Implications for Gastroesophageal Reflux Disease and Patient Quality of Life
This is a prospective randomized clinical trial evaluating the impact of antrum and fundus calibration during laparoscopic vertical gastrectomy (VG) on postoperative gastroesophageal reflux disease (GERD), quality of life, and surgical costs. Eligible participants are adults with morbid obesity (BMI ≥35 kg/m²) undergoing LSG. Patients are randomized into four groups based on whether antral and/or fundal calibration is performed. Primary outcomes include the incidence of de novo GERD at 12 months. Secondary outcomes include postoperative quality of life, vomiting , surgical complications, weight loss, and operative costs. The study aims to optimize the LSG technique by identifying anatomical modifications that minimize GERD while improving clinical outcomes
Read the detailed description
This is a prospective, randomized clinical trial conducted at the Regional University Hospital of Málaga. The objective is to evaluate the effect of antrum and fundus calibration during vertical gastrectomy (VG) on the incidence of gastroesophageal reflux disease (GERD), quality of life, weight loss, and surgical costs.
Eligibility Criteria:
Inclusion criteria include adults with an indication for VG, a body mass index (BMI) ≥ 35 kg/m², and provision of written informed consent.
Exclusion criteria include endocrine-related obesity, active gastrointestinal disease (such as GERD, esophagitis, peptic ulcer, or motility disorders), or a history of gastric surgery.
Randomization and Study Arms:
Patients are randomized to one of four groups:
Group A: No antrum or fundus calibration Group B: Fundus calibration only Group C: Antrum and fundus calibration Group D: Antrum calibration only
Surgical Protocol:
All patients receive a 36 Fr bougie to shape the gastric tube. In cases with antrum calibration, a 50 cc balloon catheter (MidSleeve®) guides the staple line. For fundus calibration, transection is performed 1 cm from the anatomical fat pad. Stapler height is adjusted according to tissue thickness, and the staple line is reinforced.
GERD Assessment:
De novo GERD is defined by endoscopic findings (esophagitis), pathological pH monitoring (DeMeester index > 14.72 or acid exposure > 4%), or clinically significant reflux symptoms with a GERD-HRQL score ≥ 12. Preoperative GERD is ruled out by endoscopy and questionnaire, followed by pH monitoring if symptoms are present.
Follow-Up and Monitoring:
Patients are followed at 2 weeks, 3, 6, and 12 months. In those reporting symptoms postoperatively, endoscopy and pHmetry are repeated.
Variables Collected:
Data include age, sex, BMI, comorbidities, operative details (e.g., number of stapler cartridges), complications (Clavien-Dindo classification), weight loss (%EWL), quality of life metrics (vomiting, regurgitation, satiety, food tolerance), and presence of GERD.
Statistical Analysis:
Comparisons are made across the four study groups, as well as pooled analyses for fundus calibration (yes vs. no) and antrum calibration (yes vs. no). Quantitative data are analyzed using Student's t-test or Mann-Whitney U test, and categorical variables by chi-square or Kruskal-Wallis test as appropriate. Spearman's correlation is used for association between variables. A p-value < 0.05 is considered statistically significant.
- Conditions
- Obese Patients (BMI ≥ 30 kg/m²), Obese Patients, Obese Patients With Bariatric Surgery, Obese With Comorbidities
- Being tested
- Antrum calibration, Fudus calibration, No antrum calibration, No fundus calibration
- Keywords
- Obesity, Vertical gastrectomy, Gastroesophageal reflux disease, Quality of life
- Medical subject headings
- Obesity, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antrum calibrationDevice
Also called Antrum section
For antral calibration, a 50 cc balloon catheter was used to guide the staple line.
Fudus calibrationProcedure or surgery
Also called fundus section
Fundus transection was performed 1 cm from the "fat pad" in calibrated cases (an anatomically constant area near the short gastric vessels that contains minimal fat and facilitates dissection toward the diaphragmatic crus).
No antrum calibrationProcedure or surgery
In patients without antrum calibration, gastric transection was performed 5 cm from the pylorus.
No fundus calibrationProcedure or surgery
Fundus transection was performed adjacent to the "fat pad" in no calibrated cases.
| Study group | Role | What they receive |
|---|---|---|
| No antrum or fundus calibration | Experimental | No antrum or fundus calibration Receives: Procedure: No antrum calibration; Procedure: No fundus calibration |
| Fundus calibration | Experimental | Fundus calibration only Receives: Procedure: Fudus calibration; Procedure: No antrum calibration |
| Antrum and fundus calibration | Experimental | Antrum and fundus calibration Receives: Device: Antrum calibration; Procedure: Fudus calibration |
| Antrum calibration | Experimental | Antrum calibration only Receives: Device: Antrum calibration; Procedure: No fundus calibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of de novo Gastroesophageal Reflux Disease (GERD)
De novo GERD will be diagnosed if any of the following criteria are met:
Presence of esophagitis according to the Los Angeles classification DeMeester index > 14.72 Acid exposure time > 4% on 24-hour pH-metry GERD-HRQL questionnaire score ≥ 12
Measured: 12 months postoperatively
Secondary outcomes (18)
Incidence of Postoperative Vomiting
Postoperative vomiting will be assessed during follow-up visits at 2 weeks, 3 months, 6 months, and 12 months. Patients will self-report the presence, frequency, and severity of vomiting episodes related to food intake.
Measured: 12 months postoperatively
Incidence of Postoperative Regurgitation
Postoperative regurgitation will be assessed during follow-up visits at 2 weeks, 3 months, 6 months, and 12 months. Patients will self-report the presence, frequency, and severity of regurgitation related to food intake. In addition, regurgitation will be evaluated using the specific item in the GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire.
Measured: 12 months postoperatively
Food intake volume per meal
Food intake volume will be assessed during follow-up visits at 2 weeks, 3 months, 6 months, and 12 months.
Measured: 12 months postoperatively
Percentage of excess weight loss (%EWL)
The percentage of excess weight loss (%EWL) will be calculated at 12 months postoperatively. %EWL is defined as:
Ideal weight will be based on a BMI of 25 kg/m². This measure evaluates the effectiveness of the procedure in achieving weight reduction
Measured: 12 months postoperatively
Change in Hypertension Status from Baseline to 12 Months Post-Surgery
Hypertension improvement or resolution will be determined by comparing preoperative and postoperative clinical records, and antihypertensive medication usage.
Measured: Baseline and within 12 months after surgery
Postoperative BMI
The Body Mass Index (BMI) will be calculated at each postoperative follow-up visit (2 weeks, 3 months, 6 months, and 12 months) to assess the evolution of weight loss. BMI is calculated as weight in kilograms divided by the square of height in meters (kg/m²)
Measured: Within 12 months after surgery
Weight loss
Weight loss will be calculated at each postoperative follow-up visit (2 weeks, 3 months, 6 months, and 12 months)
Measured: Within 12 months after surgery
Postoperative Morbidity
Postoperative complications will be assessed and classified according to the Clavien-Dindo classification system. All adverse events occurring within 30 days of surgery will be recorded and categorized by severity.
Measured: Up to 30 days after surgery
Number of stapler cartridges used
The total number of stapler cartridges used during vertical gastrectomy will be recorded for each patient.
Measured: During the surgical procedure
Intraoperative complications
All adverse events occurring during surgery will be recorded, including bleeding, injury to adjacent organs, anesthetic incidents, or other unforeseen technical difficulties
Measured: During the surgical procedure
Change in Type 2 Diabetes Mellitus Status from Baseline to 12 Months Post-Surgery
Improvement or resolution of Type 2 Diabetes Mellitus will be assessed through levels, HbA1c, and antidiabetic medication requirements
Measured: Baseline and within 12 months after surgery
Change in Hypercholesterolemia Status from Baseline to 12 Months Post-Surgery
Evaluated through serum cholesterol levels and lipid-lowering medication usage before and after surgery.
Measured: Baseline and within 12 months after surgery
Change in Obstructive Sleep Apnea Syndrome (OSAS) Status from Baseline to 12 Months Post-Surgery
Improvement or resolution based on patient-reported symptoms, CPAP usage, and clinical evaluation
Measured: Baseline and within 12 months after surgery
Change in Hypertriglyceridemia Status from Baseline to 12 Months Post-Surgery
Improvement or resolution of hypertriglyceridemia will be assessed by comparing preoperative and postoperative triglyceride levels and the need for lipid-lowering therapy
Measured: Baseline and within 12 months after surgery
Change in Postoperative Satiety Over Time
Satiety will be assessed through patient self-reported feedback during postoperative visits at 2 weeks, 3 months, 6 months, and 12 months. The evaluation includes perceived fullness after meals and the volume of food tolerated per intake.
Measured: 2 weeks, 3 months, 6 months, and 12 months postoperatively
Tolerance to Oral Liquid Intake After Surgery
Tolerance to oral liquid intake will be assessed at 2 weeks, 3 months, 6 months, and 12 months after surgery. This variable evaluates the patient's ability to ingest and retain clear liquids without nausea, vomiting, or discomfort. Data will be collected through clinical interviews, patient-reported outcomes, and medical records during scheduled follow-up visits.
Measured: 2 weeks, 3 months, 6 months, and 12 months postoperatively
Tolerance to Oral Solid Intake After Surgery
Assessment of the patient's ability to tolerate solid food intake following vertical gastrectomy. Tolerance will be evaluated based on patient self-reported ability to consume solid foods without discomfort, vomiting, or regurgitation.
Measured: 2 weeks, 3 months, 6 months, and 12 months postoperatively
Tolerance to Oral Meat Intake After Surgery
Patient-reported ability to consume and tolerate meat (solid protein) without nausea, vomiting, regurgitation, or abdominal discomfort. Data will be collected via clinical interviews at each postoperative visit
Measured: 2 weeks, 3 months, 6 months, and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start6 Apr 2020
- Primary completion31 Dec 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.
- Other trials for Obese Patients (BMI ≥ 30 kg/m²)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Juan de Dios Tenerife
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Regional de Malaga
- Responsible party
- Principal investigator, Julen Ramon Rodríguez, Hospital San Juan de Dios Tenerife
- Investigators
- Dr. Francisco Javier Moreno Ruiz, MD Head of the Bariatric Surgery Unit, Study director, Regional University Hospital of Málaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070908
- Sponsor's protocol ID
- 25-00101
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The data presented in this study are available on request from the corresponding author, in accordance with the informed consent provided by study participants and subject to patient confidentiality and data protection policies
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifications to Gastric Tube Construction in Vertical Gastrectomy: Implications for Gastroesophageal Reflux Disease and Patient Quality of Life
- ClinicalTrials.gov ID
- NCT07070908
- Acronym / sponsor ID
- 25-00101
- Conditions
- Obese Patients (BMI ≥ 30 kg/m²), Obese Patients, Obese Patients With Bariatric Surgery, Obese With Comorbidities
- Keywords
- Obesity, Vertical gastrectomy, Gastroesophageal reflux disease, Quality of life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital San Juan de Dios TenerifeUniversity, hospital or other
- Collaborators
- Hospital Regional de Malaga
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jul 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.
This is a prospective randomized clinical trial evaluating the impact of antrum and fundus calibration during laparoscopic vertical gastrectomy (VG) on postoperative gastroesophageal reflux disease (GERD), quality of life, and surgical costs. Eligible participants are adults with morbid obesity (BMI ≥35 kg/m²) undergoing LSG. Patients are randomized into four groups based on whether antral and/or fundal calibration is performed. Primary outcomes include the incidence of de novo GERD at 12 months. Secondary outcomes include postoperative quality of life, vomiting , surgical complications, weight loss, and operative costs. The study aims to optimize the LSG technique by identifying anatomical modifications that minimize GERD while improving clinical outcomes
Detailed description
This is a prospective, randomized clinical trial conducted at the Regional University Hospital of Málaga. The objective is to evaluate the effect of antrum and fundus calibration during vertical gastrectomy (VG) on the incidence of gastroesophageal reflux disease (GERD), quality of life, weight loss, and surgical costs.
Eligibility Criteria:
Inclusion criteria include adults with an indication for VG, a body mass index (BMI) ≥ 35 kg/m², and provision of written informed consent.
Exclusion criteria include endocrine-related obesity, active gastrointestinal disease (such as GERD, esophagitis, peptic ulcer, or motility disorders), or a history of gastric surgery.
Randomization and Study Arms:
Patients are randomized to one of four groups:
Group A: No antrum or fundus calibration Group B: Fundus calibration only Group C: Antrum and fundus calibration Group D: Antrum calibration only
Surgical Protocol:
All patients receive a 36 Fr bougie to shape the gastric tube. In cases with antrum calibration, a 50 cc balloon catheter (MidSleeve®) guides the staple line. For fundus calibration, transection is performed 1 cm from the anatomical fat pad. Stapler height is adjusted according to tissue thickness, and the staple line is reinforced.
GERD Assessment:
De novo GERD is defined by endoscopic findings (esophagitis), pathological pH monitoring (DeMeester index > 14.72 or acid exposure > 4%), or clinically significant reflux symptoms with a GERD-HRQL score ≥ 12. Preoperative GERD is ruled out by endoscopy and questionnaire, followed by pH monitoring if symptoms are present.
Follow-Up and Monitoring:
Patients are followed at 2 weeks, 3, 6, and 12 months. In those reporting symptoms postoperatively, endoscopy and pHmetry are repeated.
Variables Collected:
Data include age, sex, BMI, comorbidities, operative details (e.g., number of stapler cartridges), complications (Clavien-Dindo classification), weight loss (%EWL), quality of life metrics (vomiting, regurgitation, satiety, food tolerance), and presence of GERD.
Statistical Analysis:
Comparisons are made across the four study groups, as well as pooled analyses for fundus calibration (yes vs. no) and antrum calibration (yes vs. no). Quantitative data are analyzed using Student's t-test or Mann-Whitney U test, and categorical variables by chi-square or Kruskal-Wallis test as appropriate. Spearman's correlation is used for association between variables. A p-value < 0.05 is considered statistically significant.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No antrum or fundus calibration | Experimental | Procedure: No antrum calibration, Procedure: No fundus calibrationNo antrum or fundus calibration |
| Fundus calibration | Experimental | Procedure: Fudus calibration, Procedure: No antrum calibrationFundus calibration only |
| Antrum and fundus calibration | Experimental | Device: Antrum calibration, Procedure: Fudus calibrationAntrum and fundus calibration |
| Antrum calibration | Experimental | Device: Antrum calibration, Procedure: No fundus calibrationAntrum calibration only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with morbid obesity on the waiting list for bariatric surgery.
- Both male and female participants.
- Age between 18 and 65 years.
- BMI > 35 kg/m².
- Availability to attend scheduled follow-up visits.
Key exclusion criteria (5 listed)
- Obesity of endocrine origin.
- Preoperative GERD (diagnosed by pH-metry or upper endoscopy following a positive GERD-HRQL test).
- Active gastrointestinal disease (such as esophagitis, peptic ulcer, cancer, or esophageal motility disorder), diagnosed by endoscopy or manometry.
- History of previous gastric surgery.
- Patients not meeting the inclusion criteria
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 |
|---|---|---|
| Antrum calibrationAlso: Antrum sectionFor antral calibration, a 50 cc balloon catheter was used to guide the staple line. | Device | Antrum and fundus calibration, Antrum calibration |
| Fudus calibrationAlso: fundus sectionFundus transection was performed 1 cm from the "fat pad" in calibrated cases (an anatomically constant area near the short gastric vessels that contains minimal fat and facilitates dissection toward the diaphragmatic crus). | Procedure or surgery | Antrum and fundus calibration, Fundus calibration |
| No antrum calibrationIn patients without antrum calibration, gastric transection was performed 5 cm from the pylorus. | Procedure or surgery | Fundus calibration, No antrum or fundus calibration |
| No fundus calibrationFundus transection was performed adjacent to the "fat pad" in no calibrated cases. | Procedure or surgery | Antrum calibration, No antrum or fundus calibration |
Primary outcome
Incidence of de novo Gastroesophageal Reflux Disease (GERD)
Time frame: 12 months postoperatively
De novo GERD will be diagnosed if any of the following criteria are met: Presence of esophagitis according to the Los Angeles classification DeMeester index > 14.72 Acid exposure time > 4% on 24-hour pH-metry GERD-HRQL questionnaire score ≥ 12
18 secondary outcomes
Incidence of Postoperative Vomiting
Time frame: 12 months postoperatively
Incidence of Postoperative Regurgitation
Time frame: 12 months postoperatively
Food intake volume per meal
Time frame: 12 months postoperatively
Percentage of excess weight loss (%EWL)
Time frame: 12 months postoperatively
Change in Hypertension Status from Baseline to 12 Months Post-Surgery
Time frame: Baseline and within 12 months after surgery
Postoperative BMI
Time frame: Within 12 months after surgery
Weight loss
Time frame: Within 12 months after surgery
Postoperative Morbidity
Time frame: Up to 30 days after surgery
Number of stapler cartridges used
Time frame: During the surgical procedure
Intraoperative complications
Time frame: During the surgical procedure
Change in Type 2 Diabetes Mellitus Status from Baseline to 12 Months Post-Surgery
Time frame: Baseline and within 12 months after surgery
Change in Hypercholesterolemia Status from Baseline to 12 Months Post-Surgery
Time frame: Baseline and within 12 months after surgery
Change in Obstructive Sleep Apnea Syndrome (OSAS) Status from Baseline to 12 Months Post-Surgery
Time frame: Baseline and within 12 months after surgery
Change in Hypertriglyceridemia Status from Baseline to 12 Months Post-Surgery
Time frame: Baseline and within 12 months after surgery
Change in Postoperative Satiety Over Time
Time frame: 2 weeks, 3 months, 6 months, and 12 months postoperatively
Tolerance to Oral Liquid Intake After Surgery
Time frame: 2 weeks, 3 months, 6 months, and 12 months postoperatively
Tolerance to Oral Solid Intake After Surgery
Time frame: 2 weeks, 3 months, 6 months, and 12 months postoperatively
Tolerance to Oral Meat Intake After Surgery
Time frame: 2 weeks, 3 months, 6 months, and 12 months postoperatively
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 17 Jul 2025.
- Individual participant dataSharing planned: No. The data presented in this study are available on request from the corresponding author, in accordance with the informed consent provided by study participants and subject to patient confidentiality and data protection policies
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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.
Dr. Francisco Javier Moreno Ruiz, MD Head of the Bariatric Surgery Unit study director
Regional University Hospital of Málaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antrum calibration, Fudus calibration and No antrum calibration in people with Obese Patients (BMI ≥ 30 kg/m²) and Obese Patients, run by Hospital San Juan de Dios Tenerife at 1 site in Spain.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 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 Spain. 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?
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?
Incidence of de novo Gastroesophageal Reflux Disease (GERD) (time frame: 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2025.