ObesityNCT07600411
Binge Eating, Depression and Anxiety Outcomes After Sleeve Gastrectomy Versus Gastric Bypass: A Cohort Study
A study testing Laparoscopic Sleeve Gastrectomy and Gastric Bypass in people with Obesity, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if the type of weight-loss surgery (sleeve gastrectomy or gastric bypass) affects binge eating, depression, and anxiety in adults with severe obesity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Laparoscopic Sleeve Gastrectomy and Gastric Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Mar 2026to Sep 2027
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years
- Body Mass Index (BMI) ≥ 35 kg/m² without comorbidities, OR BMI ≥ 30 kg/m² with at least one obesity-related medical comorbidity (e.g., type 2 diabetes, hypertension, obstructive sleep apnea, dyslipidemia)
- Patient is generally fit for laparoscopic surgery and general anesthesia as determined by preoperative evaluation
- Patient agrees to comply with postoperative lifestyle changes (dietary modifications and follow-up schedule)
- Willing and able to provide written informed consent
Who cannot join
- Age < 18 years or > 60 years
- Inability or unwillingness to adhere to postoperative lifestyle changes
- Contraindication to surgery: American Society of Anesthesiologists (ASA) class IV or higher
- History of receiving radiotherapy or chemotherapy for cancer treatment
- Active substance use disorder or uncontrolled severe psychiatric illness that would impair ability to comply with study procedures (e.g., active psychosis, severe suicidal ideation)
- Pregnant or breastfeeding women (pregnancy test performed preoperatively per institutional protocol)
- Previous bariatric surgery (revisional surgery excluded)
- Untreated thyroid disorder (e.g., hypothyroidism or hyperthyroidism)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Cairo University
Cairo, Al-Manial Cairo, 11956
Ahmed Maher Abd Elmonim, Assistant professor, +201031036313, Ahmed.maher@kasralainy.edu.eg
Ahmed
About this study
Official title: Binge Eating, Depression and Anxiety Outcomes Following Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y or One-Anastomosis Gastric Bypass: A Prospective Cohort Study
The goal of this clinical trial is to learn if the type of weight-loss surgery (sleeve gastrectomy or gastric bypass) affects binge eating, depression, and anxiety in adults with severe obesity. The main questions it aims to answer are:
Does sleeve gastrectomy lead to different changes in binge eating compared with gastric bypass?
Read more
Does the type of surgery lead to different changes in depression and anxiety symptoms?
Researchers will compare people who have sleeve gastrectomy with those who have gastric bypass to see if there are differences in binge eating, depression, and anxiety levels up to 12 months after surgery.
Participants will:
Complete questionnaires about eating habits, mood, anxiety, general health, and body image before surgery.
Undergo either a sleeve gastrectomy or a gastric bypass operation (both are standard care).
Follow a standard post-surgery diet plan.
Attend follow-up visits at 1 week, 2 weeks, 1 month, and then monthly for 12 months, where they will complete the same questionnaires again.
Read the detailed description
This prospective cohort study compares two standard-of-care bariatric surgical procedures - laparoscopic sleeve gastrectomy (SG) and laparoscopic gastric bypass (Roux-en-Y or one-anastomosis) - with respect to postoperative changes in binge eating, depression, and anxiety. A total of 100 morbidly obese patients (50 per arm) aged 18-60 years with a body mass index ≥35 kg/m² (or ≥30 kg/m² with at least one obesity-related comorbidity) will be recruited from the General Surgery department at Kasr Alainy Teaching Hospital, Cairo University.
The choice of procedure is determined by a preoperative multidisciplinary evaluation considering baseline BMI, presence of gastroesophageal reflux disease, type 2 diabetes mellitus, and patient preference after detailed counseling. All operations are performed under general anesthesia; SG uses a 36-Fr bougie.
Validated Arabic versions of the following instruments are administered at baseline and at each postoperative visit (1 week, 2 weeks, 1 month, and monthly thereafter for 12 months):
Binge Eating Scale (BES) - primary outcome for binge eating
Beck Depression Inventory-II (BDI-II) - primary outcome for depression
Beck Anxiety Inventory (BAI) - primary outcome for anxiety
General Health Questionnaire-28 (GHQ-28)
Body Shape Questionnaire-14 (BSQ-14)
Eating Attitude Test-26 (EAT-26)
Secondary outcomes include changes in GHQ-28, BSQ-14, EAT-26 scores, and weight loss (absolute weight and BMI). Data will be analyzed using SPSS version 27, with appropriate parametric and non-parametric tests for between- and within-group comparisons. The significance level is set at p ≤ 0.05. The study is powered (80%, alpha 5%) to detect a difference in binge eating prevalence between SG (18.4%) and gastric bypass (1.3%) at one year, requiring 92 evaluable patients; 100 will be enrolled to accommodate potential loss to follow-up.
The study has been approved by the Cairo University Faculty of Medicine Research Ethics Committee (REC approval number N-64-2026, dated 7 March 2026). All participants provide written informed consent.
- Conditions
- Obesity
- Being tested
- Laparoscopic Sleeve Gastrectomy, Gastric Bypass
- Keywords
- Bariatric surgery, Binge eating, Anxiety, Depression, Body shape questionnaire, Eating attitude test
- Medical subject headings
- Obesity, Bulimia, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve GastrectomyProcedure or surgery
Laparoscopic sleeve gastrectomy performed using a 36-French bougie. The greater curvature of the stomach is resected, creating a tubular gastric sleeve. Standard perioperative care including antibiotic prophylaxis and DVT prophylaxis. Postoperative liquid diet for 15 days, then soft diet for one month, followed by gradual introduction of regular diet avoiding fatty and high-sugar foods.
Gastric BypassProcedure or surgery
Gastric bypass surgery performed either as Roux-en-Y gastric bypass (RYGB) or one anastomosis gastric bypass (OAGB) based on preoperative multidisciplinary evaluation. Includes creation of a small gastric pouch and an anastomosis to the small bowel. Standard perioperative and postoperative care same as sleeve gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Sleeve Gastrectomy (SG) | Experimental | Participants undergo laparoscopic sleeve gastrectomy using a 36-French bougie. Standard perioperative and postoperative care according to bariatric surgery protocol. Follow-up at 1 week, 2 weeks, 1 month, then monthly for 12 months. Outcome assessments include Binge Eating Scale (BES), Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), GHQ-28, BSQ-14, and EAT-26. Receives: Procedure: Laparoscopic Sleeve Gastrectomy |
| Gastric Bypass (One Anastomosis or Roux-en-Y) | Active comparator | Participants undergo gastric bypass (either one anastomosis gastric bypass - OAGB, or Roux-en-Y gastric bypass - RYGB) based on preoperative multidisciplinary evaluation. Standard perioperative and postoperative care. Same follow-up schedule and outcome assessments as the SG arm. Receives: Procedure: Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Composite Mental Health Score (Simple Sum)
Simple sum of raw scores from three scales: Binge Eating Scale (BES, 0-46) + Beck Depression Inventory-II (BDI-II, 0-63) + Beck Anxiety Inventory (BAI, 0-63). Minimum total = 0 (best mental health). Maximum total = 172 (worst mental health). Higher score = worse mental health. Primary endpoint is change from baseline to 12 months (lower score = improvement).
Measured: Baseline, 6 months, 12 months
Binge Eating Scale (BES) Score Change
16-item self-report questionnaire. Each item scored 0-3. Total raw score range: minimum 0, maximum 46. Higher score = more severe binge eating. Clinical interpretation: 0-17 = no significant binge eating; 18-26 = moderate binge eating; 27-46 = severe binge eating.
Measured: Baseline, 6 months, 12 months
Beck Depression Inventory-II (BDI-II) Score Change
21-item self-report inventory. Each item scored 0-3. Total raw score range: minimum 0, maximum 63. Higher score = more severe depression. Clinical interpretation: 0-13 = minimal depression; 14-19 = mild depression; 20-28 = moderate depression; 29-63 = severe depression.
Measured: Baseline, 6 months, 12 months
Beck Anxiety Inventory (BAI) Score Change
21-item self-report questionnaire. Each item scored 0-3. Total raw score range: minimum 0, maximum 63. Higher score = more severe anxiety. Clinical interpretation: 0-7 = minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (5)
Body Shape Questionnaire-14 (BSQ-14) Score Change
14-item self-report measure of body shape satisfaction. Each item scored 1 (never) to 6 (always). Total raw score range: minimum 14, maximum 84. Lower score = greater body shape satisfaction (better). Higher score = lower satisfaction (more dissatisfaction). Clinical interpretation: score ≤ 34 = good satisfaction; score 35-50 = moderate dissatisfaction; score >50 = marked to severe dissatisfaction (poor satisfaction).
Measured: Baseline, 6 months, 12 months
General Health Questionnaire-28 (GHQ-28) - Likert Score
28-item self-report screening tool for minor psychiatric disorders. Likert scoring (0-1-2-3 per item) is used. Total raw score range: minimum 0, maximum 84. Higher score = worse psychological distress. A total score greater than 23 suggests probable psychiatric caseness (anxiety or depression disorder). Four subscales (each 0-21): A = somatic symptoms (items 1-7), B = anxiety/insomnia (8-14), C = social dysfunction (15-21), D = severe depression (22-28).
Measured: Baseline, 6 months, 12 months
Eating Attitude Test-26 (EAT-26) Score Change
26-item screening tool for disordered eating attitudes. Scoring: Always=3, Usually=2, Often=1, Sometimes=0, Rarely=0, Never=0. Item 26 is reverse scored (Always=0, Never=3). Total raw score range: minimum 0, maximum 78. Higher score = more pathological eating attitudes. A score of 20 or higher suggests possible eating disorder (anorexia nervosa, bulimia nervosa, or binge eating disorder) and needs clinical interview.
Measured: Baseline, 6 months, 12 months
Percent Total Weight Loss (%TWL)
Calculated as: [(Baseline weight in kg - current weight in kg) / baseline weight in kg] × 100. Higher percentage = greater weight loss. Can be negative if patient gains weight. Successful weight loss after bariatric surgery is often defined as %TWL ≥ 20% at 12 months.
Measured: 6 months, 12 months
Body Mass Index (BMI) Change
Body Mass Index calculated as weight in kilograms divided by height in meters squared (kg/m²). Weight measured using a calibrated scale; height measured at baseline using a stadiometer. BMI range typically 15-60 kg/m² in this population. Lower BMI indicates healthier weight status. Clinical classification: <18.5 underweight, 18.5-24.9 normal, 25-29.9 overweight, 30-34.9 obesity class I, 35-39.9 obesity class II, ≥40 obesity class III (severe obesity).
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start11 Mar 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Eid Ali Ahmed Aziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600411
- Sponsor's protocol ID
- N-64-2026
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Binge Eating, Depression and Anxiety Outcomes Following Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y or One-Anastomosis Gastric Bypass: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07600411
- Acronym / sponsor ID
- N-64-2026
- Conditions
- Obesity
- Keywords
- Bariatric surgery, Binge eating, Anxiety, Depression, Body shape questionnaire, Eating attitude test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 20 May 2026 (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 clinical trial is to learn if the type of weight-loss surgery (sleeve gastrectomy or gastric bypass) affects binge eating, depression, and anxiety in adults with severe obesity. The main questions it aims to answer are:
Does sleeve gastrectomy lead to different changes in binge eating compared with gastric bypass?
Does the type of surgery lead to different changes in depression and anxiety symptoms?
Researchers will compare people who have sleeve gastrectomy with those who have gastric bypass to see if there are differences in binge eating, depression, and anxiety levels up to 12 months after surgery.
Participants will:
Complete questionnaires about eating habits, mood, anxiety, general health, and body image before surgery.
Undergo either a sleeve gastrectomy or a gastric bypass operation (both are standard care).
Follow a standard post-surgery diet plan.
Attend follow-up visits at 1 week, 2 weeks, 1 month, and then monthly for 12 months, where they will complete the same questionnaires again.
Detailed description
This prospective cohort study compares two standard-of-care bariatric surgical procedures - laparoscopic sleeve gastrectomy (SG) and laparoscopic gastric bypass (Roux-en-Y or one-anastomosis) - with respect to postoperative changes in binge eating, depression, and anxiety. A total of 100 morbidly obese patients (50 per arm) aged 18-60 years with a body mass index ≥35 kg/m² (or ≥30 kg/m² with at least one obesity-related comorbidity) will be recruited from the General Surgery department at Kasr Alainy Teaching Hospital, Cairo University.
The choice of procedure is determined by a preoperative multidisciplinary evaluation considering baseline BMI, presence of gastroesophageal reflux disease, type 2 diabetes mellitus, and patient preference after detailed counseling. All operations are performed under general anesthesia; SG uses a 36-Fr bougie.
Validated Arabic versions of the following instruments are administered at baseline and at each postoperative visit (1 week, 2 weeks, 1 month, and monthly thereafter for 12 months):
Binge Eating Scale (BES) - primary outcome for binge eating
Beck Depression Inventory-II (BDI-II) - primary outcome for depression
Beck Anxiety Inventory (BAI) - primary outcome for anxiety
General Health Questionnaire-28 (GHQ-28)
Body Shape Questionnaire-14 (BSQ-14)
Eating Attitude Test-26 (EAT-26)
Secondary outcomes include changes in GHQ-28, BSQ-14, EAT-26 scores, and weight loss (absolute weight and BMI). Data will be analyzed using SPSS version 27, with appropriate parametric and non-parametric tests for between- and within-group comparisons. The significance level is set at p ≤ 0.05. The study is powered (80%, alpha 5%) to detect a difference in binge eating prevalence between SG (18.4%) and gastric bypass (1.3%) at one year, requiring 92 evaluable patients; 100 will be enrolled to accommodate potential loss to follow-up.
The study has been approved by the Cairo University Faculty of Medicine Research Ethics Committee (REC approval number N-64-2026, dated 7 March 2026). All participants provide written informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Sleeve Gastrectomy (SG) | Experimental | Procedure: Laparoscopic Sleeve GastrectomyParticipants undergo laparoscopic sleeve gastrectomy using a 36-French bougie. Standard perioperative and postoperative care according to bariatric surgery protocol. Follow-up at 1 week, 2 weeks, 1 month, then monthly for 12 months. Outcome assessments include Binge Eating Scale (BES), Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), GHQ-28, BSQ-14, and EAT-26. |
| Gastric Bypass (One Anastomosis or Roux-en-Y) | Active comparator | Procedure: Gastric BypassParticipants undergo gastric bypass (either one anastomosis gastric bypass - OAGB, or Roux-en-Y gastric bypass - RYGB) based on preoperative multidisciplinary evaluation. Standard perioperative and postoperative care. Same follow-up schedule and outcome assessments as the SG arm. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 60 years
- Body Mass Index (BMI) ≥ 35 kg/m² without comorbidities, OR BMI ≥ 30 kg/m² with at least one obesity-related medical comorbidity (e.g., type 2 diabetes, hypertension, obstructive sleep apnea, dyslipidemia)
- Patient is generally fit for laparoscopic surgery and general anesthesia as determined by preoperative evaluation
- Patient agrees to comply with postoperative lifestyle changes (dietary modifications and follow-up schedule)
- Willing and able to provide written informed consent
Key exclusion criteria (8 listed)
- Age < 18 years or > 60 years
- Inability or unwillingness to adhere to postoperative lifestyle changes
- Contraindication to surgery: American Society of Anesthesiologists (ASA) class IV or higher
- History of receiving radiotherapy or chemotherapy for cancer treatment
- Active substance use disorder or uncontrolled severe psychiatric illness that would impair ability to comply with study procedures (e.g., active psychosis, severe suicidal ideation)
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 |
|---|---|---|
| Laparoscopic Sleeve GastrectomyLaparoscopic sleeve gastrectomy performed using a 36-French bougie. The greater curvature of the stomach is resected, creating a tubular gastric sleeve. Standard perioperative care including antibiotic prophylaxis and DVT prophylaxis. Postoperative liquid diet for 15 days, then soft diet for one month, followed by gradual introduction of regular diet avoiding fatty and high-sugar foods. | Procedure or surgery | Laparoscopic Sleeve Gastrectomy (SG) |
| Gastric BypassGastric bypass surgery performed either as Roux-en-Y gastric bypass (RYGB) or one anastomosis gastric bypass (OAGB) based on preoperative multidisciplinary evaluation. Includes creation of a small gastric pouch and an anastomosis to the small bowel. Standard perioperative and postoperative care same as sleeve gastrectomy. | Procedure or surgery | Gastric Bypass (One Anastomosis or Roux-en-Y) |
Primary outcome
Change in Composite Mental Health Score (Simple Sum)
Time frame: Baseline, 6 months, 12 months
Simple sum of raw scores from three scales: Binge Eating Scale (BES, 0-46) + Beck Depression Inventory-II (BDI-II, 0-63) + Beck Anxiety Inventory (BAI, 0-63). Minimum total = 0 (best mental health). Maximum total = 172 (worst mental health). Higher score = worse mental health. Primary endpoint is change from baseline to 12 months (lower score = improvement).
Binge Eating Scale (BES) Score Change
Time frame: Baseline, 6 months, 12 months
16-item self-report questionnaire. Each item scored 0-3. Total raw score range: minimum 0, maximum 46. Higher score = more severe binge eating. Clinical interpretation: 0-17 = no significant binge eating; 18-26 = moderate binge eating; 27-46 = severe binge eating.
Beck Depression Inventory-II (BDI-II) Score Change
Time frame: Baseline, 6 months, 12 months
21-item self-report inventory. Each item scored 0-3. Total raw score range: minimum 0, maximum 63. Higher score = more severe depression. Clinical interpretation: 0-13 = minimal depression; 14-19 = mild depression; 20-28 = moderate depression; 29-63 = severe depression.
Beck Anxiety Inventory (BAI) Score Change
Time frame: Baseline, 6 months, 12 months
21-item self-report questionnaire. Each item scored 0-3. Total raw score range: minimum 0, maximum 63. Higher score = more severe anxiety. Clinical interpretation: 0-7 = minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety.
5 secondary outcomes
Body Shape Questionnaire-14 (BSQ-14) Score Change
Time frame: Baseline, 6 months, 12 months
General Health Questionnaire-28 (GHQ-28) - Likert Score
Time frame: Baseline, 6 months, 12 months
Eating Attitude Test-26 (EAT-26) Score Change
Time frame: Baseline, 6 months, 12 months
Percent Total Weight Loss (%TWL)
Time frame: 6 months, 12 months
Body Mass Index (BMI) Change
Time frame: Baseline, 6 months, 12 months
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 20 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Sleeve Gastrectomy and Gastric Bypass in people with Obesity, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 8 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 20 May 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 Egypt. 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 Ahmed Eid Aziz, Lecturer (+201127060844, Ahmed-eid@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Composite Mental Health Score (Simple Sum) (time frame: Baseline, 6 months, 12 months). The study lists 4 primary outcomes in all. 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 20 May 2026.