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Efficacy of the OTSC System in the treatment of GI bleeding and wall defects: a PMCF meta-analysis.

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Title: Efficacy of the OTSC System in the treatment of GI bleeding and wall defects: a PMCF meta-analysis.
Authors: Weiland, Timo1 Timo.Weiland@novineon.com, Rohrer, Sabrina1, Schmidt, Arthur2,3, Wedi, Edris4, Bauerfeind, Peter5, Caca, Karel3, Khashab, Mouen A.6, Hochberger, Juergen7, Baur, Franziska8, Gottwald, Thomas8,9, Schurr, Marc O.8,10
Source: Minimally Invasive Therapy & Allied Technologies. Jun2020, Vol. 29 Issue 3, p121-139. 19p. 1 Diagram, 5 Charts, 4 Graphs.
Subject Terms: *GASTROINTESTINAL hemorrhage treatment, *INTESTINAL disease treatment, *CONFIDENCE intervals, *ENDOSCOPY, *META-analysis, *SYSTEMATIC reviews, *TREATMENT effectiveness, *DESCRIPTIVE statistics
Abstract: Since its market launch in 2007, the endoscopic OTSC clipping system has been the object of intensive clinical research. These data were systematically collected for post-market clinical follow-up (PMCF). The aim of the study was the systematic review of the efficacy and safety of the OTSC System. The PMCF database was systematically searched for clinical data on OTSC therapy of GI hemorrhage (H), acute leaks/perforations (AL) and chronic leaks/fistulae (CL). Major outcomes were successful clip application and durable hemostasis/closure of defects. Comprehensive pooled success proportions were established by meta-analytical methods. Four-hundred-fifty-seven publications were reviewed. Fifty-eight articles comprising 1868 patients fulfilled criteria to be included in the analysis. These consisted of retrospective analyses, prospective observational trials, one randomized-controlled trial (STING) and one quasi-controlled study (FLETRock). The pooled proportion analysis revealed high overall proportions of technical success: H – mean 93.0% [95%CI 90.2–95.4], AL-mean 89.7% [95%CI 85.9–92.9] and CL-mean 83.8% [95%CI 76.9–89.7]. Pooled durable clinical success proportions were: H-mean 87.5% [95%CI 80.5–93.2], AL-mean 81.4% [95%CI 77.0–85.3] and CL-mean 63.0% [95%CI 53.0–72.3]. By pooling all clinical data gained, we conclude that OTSC application in GI hemorrhage and closure of GI lesions is safe and effective in real clinical use. [ABSTRACT FROM AUTHOR]
Copyright of Minimally Invasive Therapy & Allied Technologies is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Efficacy of the OTSC System in the treatment of GI bleeding and wall defects: a PMCF meta-analysis.
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  Data: <searchLink fieldCode="AR" term="%22Weiland%2C+Timo%22">Weiland, Timo</searchLink><relatesTo>1</relatesTo><i> Timo.Weiland@novineon.com</i><br /><searchLink fieldCode="AR" term="%22Rohrer%2C+Sabrina%22">Rohrer, Sabrina</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Schmidt%2C+Arthur%22">Schmidt, Arthur</searchLink><relatesTo>2,3</relatesTo><br /><searchLink fieldCode="AR" term="%22Wedi%2C+Edris%22">Wedi, Edris</searchLink><relatesTo>4</relatesTo><br /><searchLink fieldCode="AR" term="%22Bauerfeind%2C+Peter%22">Bauerfeind, Peter</searchLink><relatesTo>5</relatesTo><br /><searchLink fieldCode="AR" term="%22Caca%2C+Karel%22">Caca, Karel</searchLink><relatesTo>3</relatesTo><br /><searchLink fieldCode="AR" term="%22Khashab%2C+Mouen+A%2E%22">Khashab, Mouen A.</searchLink><relatesTo>6</relatesTo><br /><searchLink fieldCode="AR" term="%22Hochberger%2C+Juergen%22">Hochberger, Juergen</searchLink><relatesTo>7</relatesTo><br /><searchLink fieldCode="AR" term="%22Baur%2C+Franziska%22">Baur, Franziska</searchLink><relatesTo>8</relatesTo><br /><searchLink fieldCode="AR" term="%22Gottwald%2C+Thomas%22">Gottwald, Thomas</searchLink><relatesTo>8,9</relatesTo><br /><searchLink fieldCode="AR" term="%22Schurr%2C+Marc+O%2E%22">Schurr, Marc O.</searchLink><relatesTo>8,10</relatesTo>
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  Data: <searchLink fieldCode="JN" term="%22Minimally+Invasive+Therapy+%26+Allied+Technologies%22">Minimally Invasive Therapy & Allied Technologies</searchLink>. Jun2020, Vol. 29 Issue 3, p121-139. 19p. 1 Diagram, 5 Charts, 4 Graphs.
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  Data: *<searchLink fieldCode="DE" term="%22GASTROINTESTINAL+hemorrhage+treatment%22">GASTROINTESTINAL hemorrhage treatment</searchLink><br />*<searchLink fieldCode="DE" term="%22INTESTINAL+disease+treatment%22">INTESTINAL disease treatment</searchLink><br />*<searchLink fieldCode="DE" term="%22CONFIDENCE+intervals%22">CONFIDENCE intervals</searchLink><br />*<searchLink fieldCode="DE" term="%22ENDOSCOPY%22">ENDOSCOPY</searchLink><br />*<searchLink fieldCode="DE" term="%22META-analysis%22">META-analysis</searchLink><br />*<searchLink fieldCode="DE" term="%22SYSTEMATIC+reviews%22">SYSTEMATIC reviews</searchLink><br />*<searchLink fieldCode="DE" term="%22TREATMENT+effectiveness%22">TREATMENT effectiveness</searchLink><br />*<searchLink fieldCode="DE" term="%22DESCRIPTIVE+statistics%22">DESCRIPTIVE statistics</searchLink>
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  Label: Abstract
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  Data: Since its market launch in 2007, the endoscopic OTSC clipping system has been the object of intensive clinical research. These data were systematically collected for post-market clinical follow-up (PMCF). The aim of the study was the systematic review of the efficacy and safety of the OTSC System. The PMCF database was systematically searched for clinical data on OTSC therapy of GI hemorrhage (H), acute leaks/perforations (AL) and chronic leaks/fistulae (CL). Major outcomes were successful clip application and durable hemostasis/closure of defects. Comprehensive pooled success proportions were established by meta-analytical methods. Four-hundred-fifty-seven publications were reviewed. Fifty-eight articles comprising 1868 patients fulfilled criteria to be included in the analysis. These consisted of retrospective analyses, prospective observational trials, one randomized-controlled trial (STING) and one quasi-controlled study (FLETRock). The pooled proportion analysis revealed high overall proportions of technical success: H – mean 93.0% [95%CI 90.2–95.4], AL-mean 89.7% [95%CI 85.9–92.9] and CL-mean 83.8% [95%CI 76.9–89.7]. Pooled durable clinical success proportions were: H-mean 87.5% [95%CI 80.5–93.2], AL-mean 81.4% [95%CI 77.0–85.3] and CL-mean 63.0% [95%CI 53.0–72.3]. By pooling all clinical data gained, we conclude that OTSC application in GI hemorrhage and closure of GI lesions is safe and effective in real clinical use. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Data: <i>Copyright of Minimally Invasive Therapy & Allied Technologies is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1080/13645706.2019.1590418
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        Text: English
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      – SubjectFull: GASTROINTESTINAL hemorrhage treatment
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