A Blinded Randomized Clinical Study of RefluxStop™ Compared With Nissen Fundoplication in the Treatment of GERD

Официальное название

A Blinded Randomized Clinical Investigation of RefluxStop™ Compared With Nissen Fundoplication in the Treatment of Gastroesophageal Reflux Disease (GERD).

Обзор

This study will evaluate if the RefluxStop™ device will treat your acid reflux and improve your symptoms and how it compares to the standard surgical treatment for GERD, the Nissen fundoplication.

Подробное описание

This study is a post-market prospective, blinded, randomized, multicenter, multi-arm clinical investigation using standard clinical procedures to record data to evaluate the safety and performance of RefluxStop™ compared with standard Nissen fundoplication for the treatment of subjects suffering from GERD.

A randomization will be performed where the Subjects will be blinded as to assigned randomization group.

Вмешательства

• Устройство RefluxStop™ implantation
  Standard surgical technique for implantation RefluxStop™, as described in the Instructions for Use
• Процедура Nissen fundoplication
  Standard surgical technique for Nissen fundoplication

Первичные конечные точки

• Patient Reported Outcomes - Side effects (PROS) evaluation [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Willing and able to provide informed consent and to participate in the clinical investigation;
• Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;
• Documented GERD present for ≥ 12 months. Typical symptoms are defined as heartburn, which is a burning sensation often presented as a substernal pain;
• 24-hour pH monitoring proven GERD with pH measurement, off PPI therapy for at least 7 days prior to testing. (Total distal esophageal pH must be < 4 for ≥ 4.5% of time during a 24-hour monitoring);
• Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator

Критерии исключения

• > 8 cm sliding hernia and paraesophageal hernia; no mesh is allowed;
• Manometry verified lack of or moderate or severe weak peristalsis in esophagus with DCI <300 or pathologic LOS function including hypercontractability, spasm or pathologic nonrelaxing functionality (the latter defined as coordinated swallows in less than 70% of wet swallows or median IRP>15mmHg). Hypercontractability defined as DCI >8'000 or pressure >45 mmHg. Thus, excluding from the study the rare diseases achalasia, scleroderma, and nutcracker esophagus, however, including mild esophageal motility disorder patients with mildly weak peristalsis;
• History of bariatric or anti-reflux surgery;
• Female subjects who are pregnant or nursing;
• Known sensitivity or allergies to silicone materials;
• Intraoperative findings determined by the investigator that may result in unfavorable conduct of the clinical investigation procedure (as outlined in the IFU);
• Subjects that are unable to comply with the clinical investigation requirements (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the clinical investigation according to the investigator's judgement);

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Германия · 2 центра

• St. Elisabethen Krankenhaus Frankfurt — Frankfurt
• Klinikum Friedrichshafen GmbH — Friedrichshafen

Австрия · 1 центр

• Universitätsklinik für Allgemeinchirurgie Klinische Abteilung für Viszeralchirurgie — Vienna

Швейцария · 1 центр

• Klinik Beau-Site Hirslanden Bern — Bern

Идентификаторы

NCT: NCT07004400 · RXI005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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