Gastrointestinal Fistula Clinical Trial
Official title:
Endoscopic Treatment of Intestinal Fistulas and Perforations
Gastrointestinal leaks or perforations are currently treated through either open or laparoscopic surgical procedures. The purpose of this research is to determine whether new endoscopic tools are safe and effective in the treatment of such conditions and can overcome the need of invasive surgical procedures.
Novel endoscopic devices have the potential to overcome the need for invasive surgery for
the treatment of gastrointestinal fistulas or perforations.
Instead of a large abdominal incision or multiple incisions with the related postoperative
morbidity endoscopic techniques will be used used which require no postoperative limitation
of activities. Using novel tissue closure devices, such as a Tissue Apposition System or an
endoscopic suturing system, we will evaluate the potential benefit, risks and impact on the
patient's quality of life of this modified surgical technique in patients having either
chronic gastrointestinal fistulas or acute perforations.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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