Back to resultsTransanal Resection of Rectal Lesions With the ColubrisMX ELS System
Primary Purpose
Rectal Adenoma, Rectal Polyp, Rectal Lesion
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ColubrisMX Endoluminal Surgical (ELS) System
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Adenoma focused on measuring Rectal Adenoma, Rectal Polyp, Rectal Lesion, Endoscopic Submucosal Dissection, Robotic Surgery, Endoluminal Surgery, Transanal Minimally Invasive Surgery, Transanal Surgery, Resection
Eligibility Criteria
Inclusion Criteria:
- Aged 22-80 years
- BMI ≤ 40 kg/m2
- ASA score ≤ 3
- Subject agrees to participate in the study by giving signed informed consent
- Benign lesion that is located ≤ 17 cm from the anal verge, such as adenoma, submucosal nodule, or polyp
- 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:
- Anatomy unsuitable for endoscopic visualization or endoluminal surgery
- Prior radiation treatment for colorectal cancer
- Subject diagnosed with ≥ T1 colorectal cancer
- Subject with distant metastases
- Subject requiring Total Mesorectal Excision
- Untreated active infection
- Vulnerable population (e.g., prisoners, mentally disabled)
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions
- Breastfeeding or pregnant, or intend to become pregnant during the course of the study
- 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
- 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.
- Subjects with immunosuppression drugs (chemotherapy) due to an increased potential for infection and poor healing
- Subjects with a high cardiac or pulmonary risk (these subjects require clearance from a cardiologist and pulmonologist)
- Subjects on preoperative blood thinners, i.e., coumadin or heparin, that cannot be weaned prior to surgery
- History of inflammatory bowel disease
Intraoperative:
- Existing stricture or anatomical blockage in lower GI tract preventing Colubriscope from reaching desired position.
- Inadequate bowel prep.
- Complex anatomical findings not feasible for endoluminal or partial thickness approach.
- 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.
- Confirmation that lesion is located further than the intended use of the ELS System (past 17 cm from the anal verge).
Sites / Locations
- EndoSurgical Center of Florida
- University Medical Center of Southern Nevada
- Memorial Hermann Southeast Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robotically assisted transanal endoluminal resection of rectal lesion
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Subjects Requiring Transfusion (percent)
Subjects Requiring Transfusion (percent) is defined as the percentage of subjects requiring transfusion prior to discharge.
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.
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.
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.
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.
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.
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.
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.
Vital Signs
Vital signs will be collected at preoperative baseline and post operative Days 7 and 30.
Clinical Laboratory Assessments
Clinical laboratory parameters will be collected at preoperative baseline and at discharge.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04651764
Brief Title
Transanal Resection of Rectal Lesions With the ColubrisMX ELS System
Official Title
Transanal Resection of Rectal Lesions With the ColubrisMX Endoluminal Surgical System (ELS System)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
June 29, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ColubrisMX
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. Study Description
Brief Summary
This study is a prospective, single-arm, multi-center, open-label, staged clinical study.
Overall Objective:
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).
To validate a program for training surgeons and their teams to successfully use the ELS System.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Adenoma, Rectal Polyp, Rectal Lesion
Keywords
Rectal Adenoma, Rectal Polyp, Rectal Lesion, Endoscopic Submucosal Dissection, Robotic Surgery, Endoluminal Surgery, Transanal Minimally Invasive Surgery, Transanal Surgery, Resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotically assisted transanal endoluminal resection of rectal lesion
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ColubrisMX Endoluminal Surgical (ELS) System
Intervention Description
Robotically assisted transanal endoluminal resection of rectal lesion using the ColubrisMX Endoluminal Surgical (ELS) System
Primary Outcome Measure Information:
Title
En Bloc Resection Rate (percent)
Description
The En Bloc Resection Rate (percent) is defined as the percentage of target lesions that are excised in a single specimen.
Time Frame
Intraoperative
Title
R0 Resection Rate (percent)
Description
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.
Time Frame
30 days
Title
Complication-Free Rate (percent)
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Conversion-Free Rate (percent)
Description
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.
Time Frame
Intraoperative
Title
Adverse Events (percent)
Description
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.
Time Frame
30 days
Title
Readmission Rate (percent)
Description
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.
Time Frame
30 days
Title
Reoperation Rate (percent)
Description
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.
Time Frame
30 days
Title
Estimated Blood Loss (mL)
Description
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.
Time Frame
Intraoperative
Title
Subjects Requiring Transfusion (percent)
Description
Subjects Requiring Transfusion (percent) is defined as the percentage of subjects requiring transfusion prior to discharge.
Time Frame
30 days
Title
Length of Stay (days)
Description
The Length of Stay (days) is the amount of days that the subject stays in the hospital related to the resection procedure.
Time Frame
30 days
Title
Mortality (percent)
Description
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.
Time Frame
30 days
Title
Fecal Incontinence (percent)
Description
Fecal Incontinence (percent) is the percentage of subjects with clinically significant disturbance to fecal continence from preoperative baseline to postoperative Day 30.
Time Frame
30 days
Title
Rate of Rectal Stricture/Stenosis (percent)
Description
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.
Time Frame
30 days
Title
Local Recurrence Rate (percent) (subjects with cancer diagnosis only)
Description
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.
Time Frame
5 years
Title
Disease Free Survival (percent) (subjects with cancer diagnosis only)
Description
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.
Time Frame
5 years
Title
Overall Survival (percent) (subjects with cancer diagnosis only)
Description
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.
Time Frame
5 years
Title
Vital Signs
Description
Vital signs will be collected at preoperative baseline and post operative Days 7 and 30.
Time Frame
30 days
Title
Clinical Laboratory Assessments
Description
Clinical laboratory parameters will be collected at preoperative baseline and at discharge.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 22-80 years
BMI ≤ 40 kg/m2
ASA score ≤ 3
Subject agrees to participate in the study by giving signed informed consent
Benign lesion that is located ≤ 17 cm from the anal verge, such as adenoma, submucosal nodule, or polyp
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:
Anatomy unsuitable for endoscopic visualization or endoluminal surgery
Prior radiation treatment for colorectal cancer
Subject diagnosed with ≥ T1 colorectal cancer
Subject with distant metastases
Subject requiring Total Mesorectal Excision
Untreated active infection
Vulnerable population (e.g., prisoners, mentally disabled)
Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions
Breastfeeding or pregnant, or intend to become pregnant during the course of the study
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
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.
Subjects with immunosuppression drugs (chemotherapy) due to an increased potential for infection and poor healing
Subjects with a high cardiac or pulmonary risk (these subjects require clearance from a cardiologist and pulmonologist)
Subjects on preoperative blood thinners, i.e., coumadin or heparin, that cannot be weaned prior to surgery
History of inflammatory bowel disease
Intraoperative:
Existing stricture or anatomical blockage in lower GI tract preventing Colubriscope from reaching desired position.
Inadequate bowel prep.
Complex anatomical findings not feasible for endoluminal or partial thickness approach.
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.
Confirmation that lesion is located further than the intended use of the ELS System (past 17 cm from the anal verge).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Wilson, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erik Askenasy, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sam Atallah, MD
Organizational Affiliation
University of Central Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ovunc Bardakcioglu, MD
Organizational Affiliation
University of Nevada, Las Vegas
Official's Role
Principal Investigator
Facility Information:
Facility Name
EndoSurgical Center of Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Memorial Hermann Southeast Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Transanal Resection of Rectal Lesions With the ColubrisMX ELS System
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