This study is a prospective, single-arm, open-label, multi-center, feasibility study to evaluate the safety and efficacy of the ColubrisMX ELS System in patients undergoing transanal endoluminal procedures, specifically colorectal Endoscopic Submucosal Dissection.
Endoscopic resection of small polyps is performed routinely through conventional outpatient colonoscopy. Larger polyps or incipient tumors can be excised with endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD). These minimally invasive procedures have been shown to be viable alternatives to conventional surgical resections with less risk of complications, shorter hospital stay and lower costs. Both flexible endoscopic and open/laparoscopic surgical approaches have procedural limitations that can have considerable impact on patient care. Traditional endoscopic tools have technical inadequacies that may inhibit the physician's ability to complete more complex tasks consistent with a surgical technique. Conversely, a traditional open or laparoscopic surgical approach involves increased risk of complications (such as surgical site infection), increased pain and blood loss, longer recovery, and surgical scars. The objective of this clinical study is to assess the safety and efficacy of the ColubrisMX Endoluminal Surgical (ELS) System, a new robotic technology designed to assist the physician with precision, flexibility, and control during endoluminal removal of colorectal lesions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Robotic Transanal Endoluminal Resection of Colorectal Lesions using the ColubrisMX Endoluminal Surgical (ELS) System
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
Rate of success (%)
Percentage of patients with no conversion during surgery and no major complications (Clavien-Dindo ≥ III complication rating) for 24 hours post-op.
Time frame: 24 hours post-op
Rate of conversions (%)
Percentage of patients with a change in treatment plan to a conventional open or laparoscopic procedure.
Time frame: Intraoperative
Estimated blood loss (mL)
Estimated amount of intraoperative blood loss (up to the point of needing transfusion).
Time frame: Intraoperative
Operative time (min)
Duration from transanal insertion of the robotic flexible overtube to final removal of the flexible overtube from the anal verge.
Time frame: Intraoperative
Patients requiring transfusion (%)
Percentage of patients requiring transfusion during surgery.
Time frame: Intraoperative
Complication rate (%)
Percentage of patients having Clavien-Dindo ≥ III intraoperatively or postoperatively at Days 7, 30, or 60.
Time frame: 60 Days
Readmission rate (%)
Percentage of patients with readmission that can be linked to colorectal submucosal dissection.
Time frame: 60 Days
Major Adverse Events (MAE) during the first 60 days
Freedom from procedural-related MAE, defined as a combined clinical endpoint of death or reoperation for failed surgical repair.
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Time frame: 60 Days