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Boston ScientificRESCUE: interruzione di GLP-1 150 Stile di vita
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La sperimentazione clinica NCT07190794 è uno studio osservazionale per Obesità, attualmente in arruolamento. Avviato il 17 dicembre 2025, prevede di arruolare 150 partecipanti. Sotto la guida di Boston Scientific, dovrebbe concludersi entro il 1 giugno 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 19 marzo 2026.
Sommario breve
This study is designed to compare weight loss outcomes and safety of ESG versus lifestyle modification in patients with obesity who discontinued GLP-1 therapy due to intolerance or suboptimal weight loss.
Descrizione dettagliata
This retrospective cohort study includes collection of data from medical records for consecutively treated patients undergoing treatment for weight loss following GLP-1 discontinuation. Weight loss treatment is either ESG with OverStitch™ OverStitch NXT™ or matched timeframe controls who participated in a lifestyle modification program for weight loss management.
Subjects will be enrolled in a 2:1 ratio (ESG: Lifest...
Mostra di piùTitolo ufficiale
Evaluation of Endoscopic Sleeve Gastroplasty (ESG) as an Alternative Weight Loss Strategy for Patients With Obesity Discontinuing GLP-1 Receptor Agonists Due to Intolerance or Ineffectiveness: A Retrospective Study
Patologie
ObesitàAltri ID dello studio
- E7234
Numero NCT
Data di inizio (effettiva)
2025-12-17
Ultimo aggiornamento pubblicato
2026-03-19
Data di completamento (stimata)
2026-06
Arruolamento (previsto)
150
Tipo di studio
Osservazionale
Stato
In arruolamento
Parole chiave
GLP-1
ESG
OverStitch
ESG
OverStitch
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
ESG Recipients After discontinuing GLP-1 medication, this group elected to have an ESG procedure as a weight loss treatment. | OverStitch™ or OverStitch NXT™ The OverStitch™ or OverStitch NXT™ Endoscopic Suturing System was used as part of each patient's ESG procedure within the routine clinical practice. |
Lifestyle Modification After discontinuing GLP-1 medication, this group elected to participate in a structured lifestyle modification program. | Modifica dello stile di vita Patients participated in a lifestyle modification program for weight loss management. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Percent total body weight loss (TBWL) at 1 year from baseline | The study will measure the percentage of total body weight loss for a period of one year from baseline. | 12 months |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in body mass index (BMI) | The study will measure change in BMI for a period of one year from baseline. | 12 months |
Percentage of excess weight loss | The study will measure the percentage of excess weight loss for a period of one year from baseline. | 12 months |
Percentage of patients that achieved 5%, 10% and 15% total body weight loss | The study will measure the percentage of patients that achieved 5%, 10% and 15% total body weight loss in the one year from baseline. | 12 months |
Metabolic markers, if available | Metabolic markers include changes from baseline in the following items:
1. HbA1c
2. Fasting blood glucose
3. Total cholesterol
4. LDL
5. HDL
6. Triglycerides
7. Blood pressure (systolic and diastolic blood pressure) | 12 months |
Visit compliance and impact to responder rate | Responders are defined as \>= 10% TBWL. This analysis will analyze if responder rate improves with higher visit compliance (number of completed interactions with a provider for weight loss management). | 12 months |
Rate of procedure-related serious adverse events within 1-year post-ESG | The study will examine the rate of procedure-related serious adverse events within 1-year post-ESG. | 12 months |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Adults (≥ 18 years)
- BMI ≥30 kg/m² and ≤ 50 kg/m2
- Discontinued GLP-1 therapy for weight loss (semaglutide and tirzepatide only) for intolerance or suboptimal weight loss (<5% TBWL after 3 months at maximally tolerated dose)
- Initiation of weight loss management no earlier than August 2021
- Completed 1-year follow-up for weight loss management (ESG and lifestyle modification or lifestyle modification alone) following initiation of weight loss treatment
- Completed at least two interim visits for weight loss management from 1, 3, 6, through 9 months following initiation of weight loss treatment
- Missing data regarding GLP-1 treatment history, including weight before GLP-1 treatment and at discontinuation, and discontinuation reason
- History of GLP-1 medication for a reason other than weight management
- Had bariatric surgery or an endoscopic procedure for weight loss treatment other than ESG with OverStitch™ or OverStitch NXT™ within 1 year of starting weight loss management
- Had an additional endoscopic treatment performed prior to or at the time of the ESG procedure that could influence weight loss results
- Had another weight loss treatment during the 1-year follow-up reported during this study. Weight loss treatment includes but is not limited to appetite suppressants, anti-obesity medications, plastic surgery or body contouring procedures.
- Pregnancy during the 1 year following initiation of weight loss management
Boston Scientific136 studi clinici attivi da esplorareContatti principali dello studio
Contatto: Katherine Stroud, 617-233-5845, [email protected]
Contatto: Pooja Goswamy, 508-683-4335, [email protected]
3 Centri dello studio in 1 paesi
Florida
Bariendo, Miami, Florida, 33179, United States
Pichamol Jirapinyo, MD, MPH, Contatto, 305-921-4219, [email protected]
In arruolamento
Massachusetts
Brigham & Women's Hospital, Boston, Massachusetts, 02115, United States
Michele Ryan, Contatto, 617-732-5500, [email protected]
Non ancora in arruolamento
West Virginia
West Virginia University, Morgantown, West Virginia, 26506, United States
Zim Warda Hasan, Contatto, 364-203-1900, [email protected]
Non ancora in arruolamento