ObesityNCT06299644
Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss
A study testing Endoscopic Sleeve Gastroplasty - Belt and Suspenders and Endoscopic Sleeve Gastroplasty - Belt in people with Obesity and Obesity, Morbid, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Obesity, Morbid, Metabolic Disease
- What is being tested?
- Endoscopic Sleeve Gastroplasty - Belt and Suspenders and Endoscopic Sleeve Gastroplasty - Belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to May 2028
- 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 18-65 years of age
- BMI ≥ 30 kg/m2
- Capable of giving informed consent and available to return for follow-up visit
Who cannot join
- Untreated H. pylori infection
- Active gastric or duodenal ulceration
- Malignant or premalignant gastric diseases (such as intestinal metaplasia, high grade dysplasia, gastric adenocarcinoma, or gastrointestinal stromal tumor (GIST))
- Severe reflux esophagitis (Los Angeles Classification (LA) Grade C or D)
- Esophageal or gastric varices and/or portal hypertensive gastropathy
- Gastroparesis
Show all 15Show fewer
- History of gastric surgery/endoscopic procedure
- Active psychological issues preventing participation in a lifestyle modification program
- Known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)
- Severe coagulopathy
- Active smoking
- Substance abuse
- Serious health condition that increased risk of anesthesia and/or endoscopic procedure
- Pregnancy or lactation
- Patients who require Non-Steroidal Anti-inflammatory Drugs (NSAID) use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss Using the Endomina Plicating Device: A Randomized Trial
The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss.
Read the detailed description
Obesity is a major global health concern. In the US, from 1999 through 2020, the prevalence of obesity has increased from 30.5% to 41.9%. Obesity, defined as the body mass index of more than 30 kg/m2, increases the risk of metabolic diseases and has become the leading cause of death including cardiovascular disease, stroke and cancers.
At present, obesity treatment ranges from lifestyle modification, pharmacotherapy, endoscopic to surgical intervention. Though bariatric surgery has proven to be the most effective treatment in terms of weight loss, it still carries the complication rates of 0.6% - 4.9%.
Endoscopic Bariatric and Metabolic Therapy (EBMT) has emerged as an alternative minimally invasive approach for the patients with morbid obesity with the body mass index (BMI) of 30 - 40 kg/m2. Endoscopic sleeve gastroplasty (ESG) involves placing sutures inside the stomach using an endoluminal full-thickness suturing device. This allows for gastric volume reduction and impaired gastric motility, which results in weight loss. Recent meta-analysis demonstrated ESG, using OverStitch suturing device, percent total weight loss (%TWL) of 16.09 - 16.43% at 12 months after procedure and a serious adverse event rate of 1 - 2.26%. With favorable outcomes and lower complication rates compared to bariatric surgery, ESG has been growing in popularity and increasingly performed worldwide. Other EBT cleared by the U.S. Food and Drug Administration for full thickness tissue approximation include the Incisionless Operating Platform endoscopic plication (USGI Medical, San Clemente, Calif, USA), and Endomina® (Endo Tools Therapeutic, Gosselies, Belgium) which creates gastric plications.
Currently, there is no standardization regarding suturing patterns. One suture pattern for gastric plication that has been used is the "belt and suspenders" pattern whereby plications sutures are placed in the distal gastric body along the width (belt) and mid/proximal gastric body (suspenders). This allows for gastric shortening and reduction in gastric volume. It is suspected this would also alter gastric motility. The distal gastric plications placed near the antrum would result in a disruption of gastric motility; decreased gastric motility would result in decrease gastric emptying and longer satiety.
- Conditions
- Obesity, Obesity, Morbid, Metabolic Disease, Weight, Body
- Being tested
- Endoscopic Sleeve Gastroplasty - Belt and Suspenders, Endoscopic Sleeve Gastroplasty - Belt
- Keywords
- Endoscopic Bariatric and Metabolic Therapies (EBMT), Endoscopic Bariatric Therapies (EBT), Gastric emptying, Endoscopic Suturing, endoscopic sleeve gastroplasty (ESG), Weight Loss, Bariatric Endoscopy, Weight Management, Endoscopic plication, Gastric plication
- Medical subject headings
- Obesity, Obesity, Morbid, Metabolic Diseases, Body Weight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Sleeve Gastroplasty - Belt and SuspendersDevice
Also called Belt and Suspenders ESG
Endoscopic sleeve gastroplasty using belt and suspender plications.
Endoscopic Sleeve Gastroplasty - BeltDevice
Also called Belt ESG
Endoscopic sleeve gastroplasty using belt only plications.
| Study group | Role | What they receive |
|---|---|---|
| Belt and Suspenders Configuration | Active comparator | Endoscopic sleeve gastroplasty with the Endomina system creating proximal and distal gastric plications (belt and suspenders configuration). Receives: Device: Endoscopic Sleeve Gastroplasty - Belt and Suspenders |
| Belt Configuration | Active comparator | Endoscopic sleeve gastroplasty with the Endomina system creating distal gastric plications (belt configuration). Receives: Device: Endoscopic Sleeve Gastroplasty - Belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent TWL (%TWL)
Change in the percent total weight loss from baseline at 6 and 12 months.
Measured: Baseline, 6 months, 12 months
Adverse Events
Presence of adverse events that develop post-procedure
Measured: 6 months, 12 months
Secondary outcomes (10)
Gastric Emptying
Comparison of gastric emptying rate using Gastric Emptying Breath Test (GEBT) from baseline to 6 months and 12 months post-procedure
Measured: Baseline, 6 month, 12 months
Number of participants with improvement in fasting glucose
Change in fasting glucose laboratory values from baseline at 6 and 12 months post-procedure
Measured: Baseline, 6 months, 12 months
Number of participants with improvement in Hemoglobin A1c (HgA1c %)
Change in HgA1c laboratory values from baseline at 6 and 12 months post-procedure
Measured: Baseline, 6 months, 12 months
Improvement in fasting lipids profile
Change in fasting lipids laboratory values from baseline at 6 and 12 months post-procedure
Measured: Baseline, 6 months, 12 months
Number of participants with a change in ghrelin hormone values
Change in ghrelin laboratory values from baseline at 6 and 12 months post-procedure
Measured: Baseline, 6 months, 12 months
Obesity-related comorbidities - hypertension
Change in hypertension diagnosis/status via change in blood pressure measurements (systolic and diastolic mm Hg) at 6 months and 12 months from baseline
Measured: Baseline, 6 months, 12 months
Obesity-related comorbidities - change in hypertension concomitant medications
Change in hypertension diagnosis/status via change blood pressure related medication dosage (mg) at 6 months and 12 months from baseline
Measured: Baseline, 6 months, 12 months
Obesity-related comorbidities - change in pre-diabetes/diabetes concomitant medications
Change in diabetes/pre-diabetes diagnosis/status via change in diabetes medications dosages (mg) at 6 months and 12 months from baseline
Measured: Baseline, 6 months, 12 months
Obesity-related comorbidities - pre-diabetes/diabetes
Change in diabetes/pre-diabetes diagnosis/status via change in HgA1c measurements (%) at 6 months and 12 months from baseline
Measured: Baseline, 6 months, 12 months
Obesity-related comorbidities - gastroesophageal reflux (GERD)
Change in GERD diagnosis/status via change in proton pump inhibitor (PPI) or related medications for treatment of GERD at 6 months and 12 months
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 posted8 Mar 2024
- Study startSep 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Endo Tools Therapeutics S.A.
- Responsible party
- Principal investigator, Christopher C. Thompson, MD, MSc, Brigham and Women's Hospital
- Investigators
- Christopher C Thompson, MD, MSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299644
- Sponsor's protocol ID
- 2023P003282
- Status last verified
- Nov 2025
- First submitted
- 1 Feb 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data will be shared with other researchers upon written request to the PI. If PI approves of the research plan, data will be released after an Institutional Data Sharing Agreement is in place.
Publications
Ibrahim AM, Ghaferi AA, Thumma JR, Dimick JB. Variation in Outcomes at Bariatric Surgery Centers of Excellence. JAMA Surg. 2017 Jul 1;152(7):629-636. doi: 10.1001/jamasurg.2017.0542.
PubMed 28445566Docimo S Jr, Aylward L, Albaugh VL, Afaneh C, El Djouzi S, Ali M, Altieri MS, Carter J; American Society for Metabolic and Bariatric Surgery Clinical Issues Committee. Endoscopic sleeve gastroplasty and its role in the treatment of obesity: a systematic review. Surg Obes Relat Dis. 2023 Nov;19(11):1205-1218. doi: 10.1016/j.soard.2023.08.020. Epub 2023 Sep 16. No abstract available.
PubMed 37813705Singh S, Hourneaux de Moura DT, Khan A, Bilal M, Ryan MB, Thompson CC. Safety and efficacy of endoscopic sleeve gastroplasty worldwide for treatment of obesity: a systematic review and meta-analysis. Surg Obes Relat Dis. 2020 Feb;16(2):340-351. doi: 10.1016/j.soard.2019.11.012. Epub 2019 Dec 10.
PubMed 31932205Li P, Ma B, Gong S, Zhang X, Li W. Efficacy and safety of endoscopic sleeve gastroplasty for obesity patients: a meta-analysis. Surg Endosc. 2020 Mar;34(3):1253-1260. doi: 10.1007/s00464-019-06889-6. Epub 2019 Jun 24.
PubMed 31236722Beran A, Matar R, Jaruvongvanich V, Rapaka BB, Alalwan A, Portela R, Ghanem O, Dayyeh BKA. Comparative Effectiveness and Safety Between Endoscopic Sleeve Gastroplasty and Laparoscopic Sleeve Gastrectomy: a Meta-analysis of 6775 Individuals with Obesity. Obes Surg. 2022 Nov;32(11):3504-3512. doi: 10.1007/s11695-022-06254-y. Epub 2022 Sep 2.
PubMed 36053446Jalal MA, Cheng Q, Edye MB. Systematic Review and Meta-Analysis of Endoscopic Sleeve Gastroplasty with Comparison to Laparoscopic Sleeve Gastrectomy. Obes Surg. 2020 Jul;30(7):2754-2762. doi: 10.1007/s11695-020-04591-4.
PubMed 32304011
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss Using the Endomina Plicating Device: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06299644
- Acronym / sponsor ID
- 2023P003282
- Conditions
- Obesity, Obesity, Morbid, Metabolic Disease, Weight, Body
- Keywords
- Endoscopic Bariatric and Metabolic Therapies (EBMT), Endoscopic Bariatric Therapies (EBT), Gastric emptying, Endoscopic Suturing, endoscopic sleeve gastroplasty (ESG), Weight Loss, Bariatric Endoscopy, Weight Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Endo Tools Therapeutics S.A.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss.
Detailed description
Obesity is a major global health concern. In the US, from 1999 through 2020, the prevalence of obesity has increased from 30.5% to 41.9%. Obesity, defined as the body mass index of more than 30 kg/m2, increases the risk of metabolic diseases and has become the leading cause of death including cardiovascular disease, stroke and cancers.
At present, obesity treatment ranges from lifestyle modification, pharmacotherapy, endoscopic to surgical intervention. Though bariatric surgery has proven to be the most effective treatment in terms of weight loss, it still carries the complication rates of 0.6% - 4.9%.
Endoscopic Bariatric and Metabolic Therapy (EBMT) has emerged as an alternative minimally invasive approach for the patients with morbid obesity with the body mass index (BMI) of 30 - 40 kg/m2. Endoscopic sleeve gastroplasty (ESG) involves placing sutures inside the stomach using an endoluminal full-thickness suturing device. This allows for gastric volume reduction and impaired gastric motility, which results in weight loss. Recent meta-analysis demonstrated ESG, using OverStitch suturing device, percent total weight loss (%TWL) of 16.09 - 16.43% at 12 months after procedure and a serious adverse event rate of 1 - 2.26%. With favorable outcomes and lower complication rates compared to bariatric surgery, ESG has been growing in popularity and increasingly performed worldwide. Other EBT cleared by the U.S. Food and Drug Administration for full thickness tissue approximation include the Incisionless Operating Platform endoscopic plication (USGI Medical, San Clemente, Calif, USA), and Endomina® (Endo Tools Therapeutic, Gosselies, Belgium) which creates gastric plications.
Currently, there is no standardization regarding suturing patterns. One suture pattern for gastric plication that has been used is the "belt and suspenders" pattern whereby plications sutures are placed in the distal gastric body along the width (belt) and mid/proximal gastric body (suspenders). This allows for gastric shortening and reduction in gastric volume. It is suspected this would also alter gastric motility. The distal gastric plications placed near the antrum would result in a disruption of gastric motility; decreased gastric motility would result in decrease gastric emptying and longer satiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belt and Suspenders Configuration | Active comparator | Device: Endoscopic Sleeve Gastroplasty - Belt and SuspendersEndoscopic sleeve gastroplasty with the Endomina system creating proximal and distal gastric plications (belt and suspenders configuration). |
| Belt Configuration | Active comparator | Device: Endoscopic Sleeve Gastroplasty - BeltEndoscopic sleeve gastroplasty with the Endomina system creating distal gastric plications (belt configuration). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with 18-65 years of age
- BMI ≥ 30 kg/m2
- Capable of giving informed consent and available to return for follow-up visit
Key exclusion criteria (15 listed)
- Untreated H. pylori infection
- Active gastric or duodenal ulceration
- Malignant or premalignant gastric diseases (such as intestinal metaplasia, high grade dysplasia, gastric adenocarcinoma, or gastrointestinal stromal tumor (GIST))
- Severe reflux esophagitis (Los Angeles Classification (LA) Grade C or D)
- Esophageal or gastric varices and/or portal hypertensive gastropathy
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 |
|---|---|---|
| Endoscopic Sleeve Gastroplasty - Belt and SuspendersAlso: Belt and Suspenders ESGEndoscopic sleeve gastroplasty using belt and suspender plications. | Device | Belt and Suspenders Configuration |
| Endoscopic Sleeve Gastroplasty - BeltAlso: Belt ESGEndoscopic sleeve gastroplasty using belt only plications. | Device | Belt Configuration |
Primary outcome
Percent TWL (%TWL)
Time frame: Baseline, 6 months, 12 months
Change in the percent total weight loss from baseline at 6 and 12 months.
Adverse Events
Time frame: 6 months, 12 months
Presence of adverse events that develop post-procedure
10 secondary outcomes
Gastric Emptying
Time frame: Baseline, 6 month, 12 months
Number of participants with improvement in fasting glucose
Time frame: Baseline, 6 months, 12 months
Number of participants with improvement in Hemoglobin A1c (HgA1c %)
Time frame: Baseline, 6 months, 12 months
Improvement in fasting lipids profile
Time frame: Baseline, 6 months, 12 months
Number of participants with a change in ghrelin hormone values
Time frame: Baseline, 6 months, 12 months
Obesity-related comorbidities - hypertension
Time frame: Baseline, 6 months, 12 months
Obesity-related comorbidities - change in hypertension concomitant medications
Time frame: Baseline, 6 months, 12 months
Obesity-related comorbidities - change in pre-diabetes/diabetes concomitant medications
Time frame: Baseline, 6 months, 12 months
Obesity-related comorbidities - pre-diabetes/diabetes
Time frame: Baseline, 6 months, 12 months
Obesity-related comorbidities - gastroesophageal reflux (GERD)
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 2 Dec 2025.
- Background: PubMed 28445566Ibrahim AM, Ghaferi AA, Thumma JR, Dimick JB. Variation in Outcomes at Bariatric Surgery Centers of Excellence. JAMA Surg. 2017 Jul 1;152(7):629-636. doi: 10.1001/jamasurg.2017.0542.
- Background: PubMed 37813705Docimo S Jr, Aylward L, Albaugh VL, Afaneh C, El Djouzi S, Ali M, Altieri MS, Carter J; American Society for Metabolic and Bariatric Surgery Clinical Issues Committee. Endoscopic sleeve gastroplasty and its role in the treatment of obesity: a systematic review. Surg Obes Relat Dis. 2023 Nov;19(11):1205-1218. doi: 10.1016/j.soard.2023.08.020. Epub 2023 Sep 16. No abstract available.
- Background: PubMed 31932205Singh S, Hourneaux de Moura DT, Khan A, Bilal M, Ryan MB, Thompson CC. Safety and efficacy of endoscopic sleeve gastroplasty worldwide for treatment of obesity: a systematic review and meta-analysis. Surg Obes Relat Dis. 2020 Feb;16(2):340-351. doi: 10.1016/j.soard.2019.11.012. Epub 2019 Dec 10.
- Background: PubMed 31236722Li P, Ma B, Gong S, Zhang X, Li W. Efficacy and safety of endoscopic sleeve gastroplasty for obesity patients: a meta-analysis. Surg Endosc. 2020 Mar;34(3):1253-1260. doi: 10.1007/s00464-019-06889-6. Epub 2019 Jun 24.
- Background: PubMed 36053446Beran A, Matar R, Jaruvongvanich V, Rapaka BB, Alalwan A, Portela R, Ghanem O, Dayyeh BKA. Comparative Effectiveness and Safety Between Endoscopic Sleeve Gastroplasty and Laparoscopic Sleeve Gastrectomy: a Meta-analysis of 6775 Individuals with Obesity. Obes Surg. 2022 Nov;32(11):3504-3512. doi: 10.1007/s11695-022-06254-y. Epub 2022 Sep 2.
- Background: PubMed 32304011Jalal MA, Cheng Q, Edye MB. Systematic Review and Meta-Analysis of Endoscopic Sleeve Gastroplasty with Comparison to Laparoscopic Sleeve Gastrectomy. Obes Surg. 2020 Jul;30(7):2754-2762. doi: 10.1007/s11695-020-04591-4.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with other researchers upon written request to the PI. If PI approves of the research plan, data will be released after an Institutional Data Sharing Agreement is in place.
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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.
Christopher C Thompson, MD, MSc principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Sleeve Gastroplasty - Belt and Suspenders and Endoscopic Sleeve Gastroplasty - Belt in people with Obesity and Obesity, Morbid, run by Brigham and Women's Hospital at 1 site in United States.
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 15 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: opening soon, as of the sponsor's last update on 2 Dec 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 United States. 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 Michele B Ryan, MS (617-525-8266, mryan@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent TWL (%TWL) (time frame: Baseline, 6 months, 12 months). The study lists 2 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 NCT06299644, which also lists 6 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 2 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.