Resection of mucosa of human colon or rectal tissue using a new endoscopic device, the SuMO (Sub Mucosal Operation) Tissue Access and Resection System

Resection of mucosa of human colon or rectal tissue using a new endoscopic device, the SuMO (Sub Mucosal Operation) Tissue Access and Resection System - Endoscopic mucosal resection in the colon and rectum using SuMO

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34055

Enrollment

Registered

2011-03-01

Start date

2011-02-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polyp

Interventions

Mucosal resection using the SuMO system in healthy colonic tissue in group A. Mucosal resection of benign mucosal lesion in colon or rectal tissue using the SuMO.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * The patient is between 18 and 80 years of age. * The patient is willing to be available for the appropriate follow-up for the duration of the study * Written informed consent;Group A: * Indication for a partial colon resection via laparoscopy or laparotomy for a benign or malignant lesion. Group B: * Indication for an endoscopic mucosal resection (EMR) for a benign rectal lesion. * Diameter of lesion

Exclusion criteria

Exclusion criteria: * The patient is not between 18 and 80 years of age. * The patient is unwilling to be available for the appropriate follow-up for the duration of the study. * The patient is mentally incompetent and does not understand the procedure and associated risks. * The patient is unable and/or unwilling to cooperate with study procedures or required follow-up visits. * The patient has any of the following conditions: o Recent myocardial infarction (acute MI) o Bleeding disorders/anticoagulation (non-reversible bleeding disorders or coagulopathy) o Prior colorectal surgery o Pregnant or actively breastfeeding. o Any other condition or anatomical limitation that would contraindicate them for laparoscopic surgery, a lower GI endoscopic procedure, or surgical anesthesia.;Group A: * ASA class IV or V * Patient is suffering from any of the following conditions: o Crohn*s Disease;Group B: * ASA class IV or V * Patient is suffering from any of the following conditions: o Crohn*s Disease o Severe diverticulitis o Previous rectal ESD or EMR

Design outcomes

Primary

Measure	Time frame
Feasibility and safety of mucosal resection of colonic or rectal tissue using the SuMO Access and Tissue Resection System. Adverse events, serious adverse events, unexpected adverse events.	—

Secondary

Measure	Time frame
Group A: * bloodloss * en bloc resection Group B: * En bloc resection * Macroscopic radical resection	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)