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Novo estudo clínico multicentros irá examinar os benefícios da terapia por Stretta em pacientes com DRGE após gastrectomia vertical
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News provided by

Mederi Therapeutics Inc.

May 11, 2016, 01:40 ET

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NORWALK, Connecticut, 11 de maio de 2016 /PRNewswire/ -- A Mederi Therapeutics anunciou hoje a realização de um novo estudo clínico multicentros que irá examinar os benefícios da terapia por Stretta como opção de tratamento de pacientes com doença do refluxo gastroesofágico (DRGE), após gastrectomia vertical (SG -- sleeve gasgtrectomy).

O estudo, intitulado "Examinando o benefício do tratamento por radiofrequência (Stretta) da DRGE após gastrectomia vertical", inclui 15 dos principais programas bariátricos nos EUA. O estudo clínico multicentros irá examinar pacientes com DRGE documentada no mínimo de seis meses após a gastrectomia vertical. O estudo irá se focar no controle dos sintomas da DRGE (HRQL) após a terapia por Stretta, com acompanhamento aos seis, 12 e 24 meses.

A gastrectomia vertical (ou gastrectomia em manga) é o procedimento preferencial para perda de peso, representando 51% das cirurgias bariátricas realizadas nos EUA em 2014 (contra 42% em 2013). Normalmente, os pacientes preferem a gastrectomia vertical ao bypass gástrico porque ela permite que o estômago retenha sua função normal.

O pesquisador principal e professor assistente de Cirurgia no Centro Médico Montefiore e na Escola de Medicina Albert Einstein, Erin Moran-Atkins, MD, associado do Colégio Americano de Cirurgiões (FACS), explicou os desafios de se tratar pacientes com DRGE após uma gastrectomia vertical: "Os pacientes obesos sentem a DRGE em taxas substancialmente mais altas do que a média da população. A cirurgia para perda de peso resolve o problema da DRGE em alguns pacientes, mas para outros os sintomas continuam. Os pacientes submetidos a gastrectomia vertical também podem ter dificuldades para tolerar medicamentos comuns para a DRGE e querem evitar uma conversão para um bypass gástrico, que tem sido o padrão de procedimento seguinte".

O copesquisador W. Scott Melvin, MD, FACS, diretor geral de Cirurgia do Centro Médico Montefiore e professor de Cirurgia na Escola de Medicina Albert Einstein, observou ainda que as opções são limitadas para pacientes com DRGE submetidos à gastrectomia vertical. "Por causa da anatomia alterada da gastrectomia vertical, não se pode realizar uma fundoplicatura. Além disso, a conversão para bypass gástrico tem uma taxa mais alta de complicações. A terapia por Stretta tem sido amplamente estudada em pacientes com anatomia alterada pela cirurgia. Mais importante, para os pacientes bariátricos, receber o Stretta não exclui uma cirurgia adicional. Estamos ansiosos para confirmar os dados de que o Stretta pode ajudar a crescente população de paciente bariátricos com DRGE".

Estudos mostram que até 84% dos pacientes com DRGE pré-existente continuam a sentir os sintomas da doença após uma gastrectomia vertical e pelo menos 8% deles desenvolvem nova DRGE pós-operatória.

A terapia por Stretta é um procedimento não cirúrgico para DRGE, que usa energia de radiofrequência (RF) para regenerar o músculo entre o estômago e o esôfago. Estudos mostram que a terapia por Stretta resolve os sintomas do refluxo, melhora a qualidade de vida, reduz ou elimina medicação e diminui a exposição a ácidos em pacientes com DRGE crônica. O Stretta é colocado transoralmente e não altera a anatomia, tornando o procedimento uma opção viável para pacientes com DRGE, que se submeteram à cirurgia bariátrica.

SOBRE O STRETTA®
A terapia por Stretta é uma opção versátil, não cirúrgica, para pacientes com DRGE, que não respondem bem a medicamentos e querem evitar a cirurgia. O Stretta foi objeto de mais de 40 estudos, todos apresentando um alto nível de segurança e eficácia. Fabricado pela Mederi Therapeutics, o Stretta está disponível em todo o mundo.

Para mais informações, contate: [email protected]

Contato: Mike Elofer
[email protected]
(484) 620-6167

FONTE Mederi Therapeutics Inc.

Related Links

http://www.mederitherapeutics.com

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