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Boston ScientificRESCUE: Discontinuation of GLP-1 150 Estilo de vida
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07190794 é um estudo observacional para Obesidade. Seu status atual é: em recrutamento. O estudo começou em 17 de dezembro de 2025 e pretende incluir 150 participantes. Coordenado por Boston Scientific e deve ser concluído em 1 de junho de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 19 de março de 2026.
Resumo
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.
Descrição detalhada
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...
Mostrar maisTítulo oficial
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
Condições médicas
ObesidadeOutros IDs do estudo
- E7234
Número NCT
Data de início (real)
2025-12-17
Última atualização postada
2026-03-19
Data de conclusão (estimada)
2026-06
Inscrição (estimada)
150
Tipo de estudo
Observacional
Status
Em recrutamento
Palavras-chave
GLP-1
ESG
OverStitch
ESG
OverStitch
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
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. | Modificação do estilo de vida Patients participated in a lifestyle modification program for weight loss management. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- 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 estudos clínicos ativos para explorarContato central do estudo
Contato: Katherine Stroud, 617-233-5845, [email protected]
Contato: Pooja Goswamy, 508-683-4335, [email protected]
3 Locais do estudo em 1 países
Florida
Bariendo, Miami, Florida, 33179, United States
Pichamol Jirapinyo, MD, MPH, Contato, 305-921-4219, [email protected]
Em recrutamento
Massachusetts
Brigham & Women's Hospital, Boston, Massachusetts, 02115, United States
Michele Ryan, Contato, 617-732-5500, [email protected]
Ainda não recrutando
West Virginia
West Virginia University, Morgantown, West Virginia, 26506, United States
Zim Warda Hasan, Contato, 364-203-1900, [email protected]
Ainda não recrutando