Colon DiseaseSUMONCT01322737
Feasibility Trial to Evaluate the Ability of the SuMO Tissue Access and Resection System
A study testing Tissue Access and Resection System in people with Colon Disease and Gastric Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
This feasibility trial will evaluate the ability of the SuMO Tissue Access and Resection System (Apollo Endosurgery, Austin, Texas). The SuMO System utilizes balloons to create a submucosal pocket and electrosurgical cutting device to resect the mucosa. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Disease, Gastric Disease
- What is being tested?
- Tissue Access and Resection System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female over 18 years of age
- Established indication for open or laparoscopic or colon resection or gastrectomy
- Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form
Who cannot join
- Subjects that are minors or prisoners
- Subjects who would have difficulty comprehending or complying with the requirements of the study
- Subjects who fail to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Evaluation of a Novel Endoscopic Polypectomy Device in Excised Human Colon and Gastric Tissue.
This feasibility trial will evaluate the ability of the SuMO Tissue Access and Resection System (Apollo Endosurgery, Austin, Texas). The SuMO System utilizes balloons to create a submucosal pocket and electrosurgical cutting device to resect the mucosa. The SuMO elevates the tissue from the underlying muscularis using a balloon to distend the submucosa, similar to what is currently performed with injectable saline in a standard EMR. After dissection of the lesion, a separate cutting device will be utilized to resect the tissue by cutting around the border of the targeted tissue. If needed, a standard loop snare will be used to complete the mucosal resection.
Read the detailed description
The subject will already be scheduled for segmental colectomy or gastrectomy.
The colectomy or gastrectomy specimen will be prepared on a side table for an ex vivo endoscopic procedure. The ends of the stomach or colon, if not already stapled closed will be ligated to allow for insufflation. The endoscope will be placed into the excised organ and the SuMO System devices will be deployed away from any areas of excised pathologic tissue, so as not to disrupt the pathologist's evaluation of the excised tissue. The specimen will then be opened and grossly examined for the actual completeness of the submucosal pocket and resection. Mucosal and muscular wall disruptions will be assessed. Again, no interference in the underlying pathology will be performed. If sufficient specimen is present, the SuMO procedure may be repeated on the same specimen.
Following the performance of the EMR by the SUMO balloon system on the ex vivo colon specimen, both the resected piece of tissue and the site of resection will be evaluated pathologically by H and E staining. Specifically, the depth of resection in the ex vivo colon specimen will be determined. In addition, the level of dissection on the removed piece of mucosa will also be identified.
During this procedure still images or a video recording maybe captured, however all images will be taken of the removed specimen. There will not be any patient identifiers on any of the images or DVD's taken during the procedure.
No clinical follow up is required, as the treated area will have already been resected and there is no risk to the patient.
- Conditions
- Colon Disease, Gastric Disease
- Being tested
- Tissue Access and Resection System
- Keywords
- resection, open, laparoscopic, benign, malignant, disease, colon, gastric
- Medical subject headings
- Colonic Diseases, Stomach Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Access and Resection SystemProcedure or surgery
Also called SUMO Tissue Access and Resection System
This feasibility trial will assess the effectiveness of SuMO System to create a submucosal pocket and resect the overlying mucosa in excised human colonic or gastric tissue
| Study group | Role | What they receive |
|---|---|---|
| SUMO Tissue Access and Resection System | Experimental | Not described Receives: Procedure: Tissue Access and Resection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of the ability of the SUMO device to create a submucosal pocket and resect the overlying mucosa in human colon or stomach.
Assess the feasibility of the SuMO device for creation of a submucosal pocket and resecting the overlying mucosa in a segment of excised human colon or stomach.
Measured: (day one)The colon or stomach tissue is evaluated in the Operating Room immediatley following excision. Subjects are not followed after using the excised tissue in the operating room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Apollo Endosurgery, Inc.
- Responsible party
- Principal investigator, Jeffrey Marks, MD, University Hospitals Cleveland Medical Center
- Investigators
- Jeffrey Marks, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322737
- Sponsor's protocol ID
- 06-10-21
- Acronym
- SUMO
- Status last verified
- Dec 2014
- First submitted
- 7 Mar 2011
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Endoscopic Polypectomy Device in Excised Human Colon and Gastric Tissue.
- ClinicalTrials.gov ID
- NCT01322737
- Acronym / sponsor ID
- SUMO / 06-10-21
- Conditions
- Colon Disease, Gastric Disease
- Keywords
- resection, open, laparoscopic, benign, malignant, disease, colon, gastric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Apollo Endosurgery, Inc.
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This feasibility trial will evaluate the ability of the SuMO Tissue Access and Resection System (Apollo Endosurgery, Austin, Texas). The SuMO System utilizes balloons to create a submucosal pocket and electrosurgical cutting device to resect the mucosa. The SuMO elevates the tissue from the underlying muscularis using a balloon to distend the submucosa, similar to what is currently performed with injectable saline in a standard EMR. After dissection of the lesion, a separate cutting device will be utilized to resect the tissue by cutting around the border of the targeted tissue. If needed, a standard loop snare will be used to complete the mucosal resection.
Detailed description
The subject will already be scheduled for segmental colectomy or gastrectomy.
The colectomy or gastrectomy specimen will be prepared on a side table for an ex vivo endoscopic procedure. The ends of the stomach or colon, if not already stapled closed will be ligated to allow for insufflation. The endoscope will be placed into the excised organ and the SuMO System devices will be deployed away from any areas of excised pathologic tissue, so as not to disrupt the pathologist's evaluation of the excised tissue. The specimen will then be opened and grossly examined for the actual completeness of the submucosal pocket and resection. Mucosal and muscular wall disruptions will be assessed. Again, no interference in the underlying pathology will be performed. If sufficient specimen is present, the SuMO procedure may be repeated on the same specimen.
Following the performance of the EMR by the SUMO balloon system on the ex vivo colon specimen, both the resected piece of tissue and the site of resection will be evaluated pathologically by H and E staining. Specifically, the depth of resection in the ex vivo colon specimen will be determined. In addition, the level of dissection on the removed piece of mucosa will also be identified.
During this procedure still images or a video recording maybe captured, however all images will be taken of the removed specimen. There will not be any patient identifiers on any of the images or DVD's taken during the procedure.
No clinical follow up is required, as the treated area will have already been resected and there is no risk to the patient.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SUMO Tissue Access and Resection System | Experimental | Procedure: Tissue Access and Resection System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female over 18 years of age
- Established indication for open or laparoscopic or colon resection or gastrectomy
- Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form
Key exclusion criteria (3 listed)
- Subjects that are minors or prisoners
- Subjects who would have difficulty comprehending or complying with the requirements of the study
- Subjects who fail to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Access and Resection SystemAlso: SUMO Tissue Access and Resection SystemThis feasibility trial will assess the effectiveness of SuMO System to create a submucosal pocket and resect the overlying mucosa in excised human colonic or gastric tissue | Procedure or surgery | SUMO Tissue Access and Resection System |
Primary outcome
Evidence of the ability of the SUMO device to create a submucosal pocket and resect the overlying mucosa in human colon or stomach.
Time frame: (day one)The colon or stomach tissue is evaluated in the Operating Room immediatley following excision. Subjects are not followed after using the excised tissue in the operating room.
Assess the feasibility of the SuMO device for creation of a submucosal pocket and resecting the overlying mucosa in a segment of excised human colon or stomach.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
Related trials for Colon Disease
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Marks, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue Access and Resection System in people with Colon Disease and Gastric Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of the ability of the SUMO device to create a submucosal pocket and resect the overlying mucosa in human colon or stomach. (time frame: (day one)The colon or stomach tissue is evaluated in the Operating Room immediatley following excision. Subjects are not followed after using the excised tissue in the operating room.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.