An interventional study of LifeSeal™ Kit in Rectal Cancer, sponsored by LifeBond Ltd.. Completed at 8 sites in 3 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-08-30.
Sponsored by LifeBond Ltd. (part of Becton, Dickinson and Company) · Not applicable, Interventional, and Treatment
A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.
1,804 studies on the registry are indexed under Rectal Neoplasms; 520 are open to participants now.
This study's enrollment of 70 is close to the median of 66 across 1,330 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →LifeBond Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The anastomosis will be created using Standard of Care only
The anastomosis will be created using SOC + LifeSeal™ Kit
Device: LifeSeal™ Kit
Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events.
Time frame: Up to 15 weeks
Performance Rate of anastomotic leak (both radiological and clinical leaks)
Time frame: Up to 15 weeks post procedure or at stoma closure, whichever comes first
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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