Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04651764
Other study ID # CMX-CSP-CS003
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date June 29, 2026

Study information

Verified date August 2021
Source ColubrisMX
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Endoscopic Mucosal Resection (EMR) is the current standard treatment for non-malignant colorectal polyps in the United States. Large colorectal polyps are most often removed piecemeal when using EMR, as en-bloc resection becomes increasingly challenging with increasing lesion size. The major drawback of EMR is its low en-bloc resection rate. The piecemeal nature of the resection hinders margin assessment, which consequently results in low R0 resection rates and causes uncertainty regarding the appropriate treatment plan for the patient going forward. This outcome results in surveillance colonoscopies at shorter intervals to evaluate for recurrence, which in turn, increases patient anxiety and poses a burden on the healthcare system. Endoscopic Submucosal Dissection (ESD) enables en bloc resection and therefore improved histopathological assessment of margins and has been reported to have highly improved R0 resection rates when compared with EMR. ESD is a common treatment option for large colorectal lesions in Asia; however, the technical difficulty and steep learning curve, which are mainly attributed to the lack of traction and countertraction capability, have resulted in low adoption of ESD in the United States. The ColubrisMX Endoluminal Surgical (ELS) System represents a marked advancement in the removal of non-malignant colorectal lesions. Robotic-assisted instrumentation with bimanual dexterity allows for application of traction and counter-traction and closure of the defect via suturing, and enables the technically challenging, single-handed ESD procedure to be conducted via a two-handed, robotic-assisted, transanal endoluminal surgical approach. The ELS System consists of two main components: the Patient Cart and the Surgeon Console. This system gains access by means of a flexible overtube (Colubriscope) that can be manually inserted up to 17 cm into the distal colon. The ELS System provides full visualization of the surgical site and the ability to manipulate up to two surgical instruments and a robotic-assisted third-party flexible endoscope (Olympus GIF-XP190), which is referred to as the "videoscope". The ELS Surgical Instruments are robotically assisted with full triangulation and articulation with up to 7 degrees of freedom to provide enhanced dexterity in narrow endoluminal anatomy.


Recruitment information / eligibility

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).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ColubrisMX Endoluminal Surgical (ELS) System
Robotically assisted transanal endoluminal resection of rectal lesion using the ColubrisMX Endoluminal Surgical (ELS) System

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
ColubrisMX

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Terminated NCT04977401 - EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection N/A
Not yet recruiting NCT05776381 - The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp Phase 2
Enrolling by invitation NCT03700593 - Feasibility and Safety of Single Port Robot in Colorectal Procedures
Active, not recruiting NCT04889352 - Optimizing Timing of Follow-up Colonoscopy N/A
Not yet recruiting NCT02579330 - Trial on Use of Coloshield in Transanal and Anal Surgery N/A
Recruiting NCT06286956 - Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device N/A