Rectal Polyp Clinical Trial
Official title:
Transanal Resection of Rectal Lesions With the ColubrisMX Endoluminal Surgical System (ELS System)
Verified date | August 2021 |
Source | ColubrisMX |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a prospective, single-arm, multi-center, open-label, staged clinical study. Overall Objective: 1. To evaluate the safety and effectiveness of the ELS System in subjects undergoing transanal endoluminal procedures in the rectum and distal colon (up to 17 cm from the anal verge). 2. To validate a program for training surgeons and their teams to successfully use the ELS System.
Status | Active, not recruiting |
Enrollment | 26 |
Est. completion date | June 29, 2026 |
Est. primary completion date | June 29, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Aged 22-80 years 2. BMI = 40 kg/m2 3. ASA score = 3 4. Subject agrees to participate in the study by giving signed informed consent 5. Benign lesion that is located = 17 cm from the anal verge, such as adenoma, submucosal nodule, or polyp 6. Lesion size is = 7 cm, with size determined according to the American College of Gastroenterology (ACGE) and the American College of Colon and Rectal Surgeons (ACCRS) guidelines as the dimension of the lesion that is greatest in extent. Exclusion Criteria: Preoperative: 1. Anatomy unsuitable for endoscopic visualization or endoluminal surgery 2. Prior radiation treatment for colorectal cancer 3. Subject diagnosed with = T1 colorectal cancer 4. Subject with distant metastases 5. Subject requiring Total Mesorectal Excision 6. Untreated active infection 7. Vulnerable population (e.g., prisoners, mentally disabled) 8. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions 9. Breastfeeding or pregnant, or intend to become pregnant during the course of the study 10. Currently enrolled in or discontinued within the last 30 days from a clinical trial of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study 11. In the opinion of the Investigator, the subject is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. 12. Subjects with immunosuppression drugs (chemotherapy) due to an increased potential for infection and poor healing 13. Subjects with a high cardiac or pulmonary risk (these subjects require clearance from a cardiologist and pulmonologist) 14. Subjects on preoperative blood thinners, i.e., coumadin or heparin, that cannot be weaned prior to surgery 15. History of inflammatory bowel disease Intraoperative: 1. Existing stricture or anatomical blockage in lower GI tract preventing Colubriscope from reaching desired position. 2. Inadequate bowel prep. 3. Complex anatomical findings not feasible for endoluminal or partial thickness approach. 4. Lesion demonstrates characteristics indicative of cancer, such as failure to lift upon submucosal injection, or any other features that raise the Investigator's suspicion of cancer. 5. Confirmation that lesion is located further than the intended use of the ELS System (past 17 cm from the anal verge). |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Hermann Southeast Hospital | Houston | Texas |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | EndoSurgical Center of Florida | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
ColubrisMX |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | En Bloc Resection Rate (percent) | The En Bloc Resection Rate (percent) is defined as the percentage of target lesions that are excised in a single specimen. | Intraoperative | |
Primary | R0 Resection Rate (percent) | The R0 Resection Rate (percent) is defined as the percentage of target lesions that have lateral and deep margins that are free of neoplasia under microscopic visualization. | 30 days | |
Primary | Complication-Free Rate (percent) | The Complication-Free Rate (percent) is defined as the percentage of subjects free from complications graded as Clavien-Dindo = III intraoperatively or postoperatively through Day 30. | 30 days | |
Secondary | Conversion-Free Rate (percent) | The Conversion-Free Rate (%) is defined as the percentage of intended procedures that do not require conversion to another platform (e.g., TAMIS or TEM) or surgical modality (i.e., laparoscopic or open surgery) to achieve successful completion. | Intraoperative | |
Secondary | Adverse Events (percent) | Data on adverse events will be collected during and after surgery. Each adverse event will be evaluated to determine the severity, relationship to the investigational device, action taken with respect to the investigational device, outcome, etc. Adverse events will be classified as mild, moderate, severe, or life-threatening. | 30 days | |
Secondary | Readmission Rate (percent) | The Readmission Rate (percent) is defined as the percentage of subjects with readmission that can be linked to the resection procedure requiring an interventional procedure up to 30 days after surgery. | 30 days | |
Secondary | Reoperation Rate (percent) | The Reoperation Rate (percent) is defined as the percentage of subjects requiring reoperation that can be linked to the resection procedure up to 30 days after surgery. | 30 days | |
Secondary | Estimated Blood Loss (mL) | Estimated Blood Loss (mL) is the amount of intraoperative blood loss (up to the point of needing transfusion). Estimated Blood Loss will be categorized as Significant, if transfusion is required, or Not Significant, if transfusion is not required. | Intraoperative | |
Secondary | Subjects Requiring Transfusion (percent) | Subjects Requiring Transfusion (percent) is defined as the percentage of subjects requiring transfusion prior to discharge. | 30 days | |
Secondary | Length of Stay (days) | The Length of Stay (days) is the amount of days that the subject stays in the hospital related to the resection procedure. | 30 days | |
Secondary | Mortality (percent) | Mortality (percent) is the percentage of subjects with a mortality from any cause up to 30 days, regardless of whether it was device/procedure-related or not. | 30 days | |
Secondary | Fecal Incontinence (percent) | Fecal Incontinence (percent) is the percentage of subjects with clinically significant disturbance to fecal continence from preoperative baseline to postoperative Day 30. | 30 days | |
Secondary | Rate of Rectal Stricture/Stenosis (percent) | A proctoscopic exam will be performed to assess rectal stricture/stenosis at 30 days post-procedure. Incidence of rectal stricture/stenosis detected at or before this follow-up visit will be recorded. | 30 days | |
Secondary | Local Recurrence Rate (percent) (subjects with cancer diagnosis only) | In subjects with lesions upstaged to histologically confirmed cancerous lesions post-resection with the ELS System, local recurrence will be monitored via five-year follow-up according to NCCN rectal cancer guidelines. The rate of local recurrence (%) in these subjects will be recorded. | 5 years | |
Secondary | Disease Free Survival (percent) (subjects with cancer diagnosis only) | In subjects with lesions upstaged to histologically confirmed cancerous lesions post-resection with the ELS System, disease free survival will be monitored via five-year follow-up according to NCCN rectal cancer guidelines. The rate of disease-free survival (%) in these subjects will be recorded. | 5 years | |
Secondary | Overall Survival (percent) (subjects with cancer diagnosis only) | In subjects with lesions upstaged to histologically confirmed cancerous lesions post-resection with the ELS System, overall survival will be monitored via five-year follow-up according to NCCN rectal cancer guidelines. The rate of overall survival (%) in these subjects will be recorded. | 5 years | |
Secondary | Vital Signs | Vital signs will be collected at preoperative baseline and post operative Days 7 and 30. | 30 days | |
Secondary | Clinical Laboratory Assessments | Clinical laboratory parameters will be collected at preoperative baseline and at discharge. | 1 day |
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