Transanal Resection of Rectal Lesions With the ColubrisMX ELS System
Stopped early · Not applicable
Conditions studied: Rectal Adenoma, Rectal Polyp, Rectal Lesion
In brief
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.
Key facts
- Study ID
- NCT04651764
- Run by
- ColubrisMX
- People needed
- 26
- Starts
- 2020-09-15
- Expected to finish
- 2021-06-29
- Last updated by the study team
- 2024-10-26
Who can join
Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- EndoSurgical Center of Florida — Orlando, Florida, United States
- University Medical Center of Southern Nevada — Las Vegas, Nevada, United States
- Memorial Hermann Southeast Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.