The SuMO System showed good results for mucosal resection in a porcine model. This study is developed to evaluate the feasibility and safety of the SuMO (submucosal operation) Access and Tissue Resection System in human colon and rectum tissue.
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Group A:
* bloodloss
* en bloc resection
Group B:
* En bloc resection
* Macroscopic radical resection
Background summary
Endoscopic mucosal resection (EMR) is used for the treatment of benign or
(pre)neoplastic mucosal lesions of the digestive tract. EMR is used when it is
not possible to perform a polypectomy. Larger lesions, more than 2 cm are often
not possible to treat with EMR. Patients than have to be treated surgicaly. The
SuMO (submucosal operation) Access and Tissue Resection System is developed to
treat these lesions. For these patients major surgical resections and
operations could be avoided with additionaly less morbidity.
Study objective
The SuMO System showed good results for mucosal resection in a porcine model.
This study is developed to evaluate the feasibility and safety of the SuMO
(submucosal operation) Access and Tissue Resection System in human colon and
rectum tissue.
Study design
Prospective cohort study
Intervention
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.
Study burden and risks
Patient burden in group A will be an extra 30 minutes that are added to the
total procedure time. For group B no extra burden other than the burden
associated with EMR. Possible risks for both groups are risks that are
associated with standard surgical or endoscopic care. For endoscopy this will
be the risk of perforation, bleeding and infection. Additionaly, risks of
anasthetics.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
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 < 4cm
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34626.018.10 |