BridgeMD
New treatment option for Colorectal Lesion
Official title PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
ClinicalTrials.gov ID: NCT06133387
What this study is testing
- What it's testing
- The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection (ESD), with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Preoperative
- Subject is ≥22 years at the time of consent.
- Subject has a BMI ≤ 50 kg/m2.
- Subject has an ASA score of ≤ 3.
- Subject has benign lesion(s) of the rectum or sigmoid colon, such as adenoma (with low- or high-grade dysplasia), neuroendocrine tumor, or other type...
You likely can't join if
- Subject anatomy is unsuitable for endoscopic visualization or endoluminal surgery.
- Subject has active left-sided inflammatory bowel disease.
- Subject has an untreated active infection at the time of the procedure.
- Subject is considered part of a vulnerable population (e.g., prisoners, mentally disabled).
- Subject has a severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (e.g., cancer).
- Subject is breastfeeding or pregnant or intends to become pregnant during the study.
See the full eligibility criteria
- Preoperative
- Subject is ≥22 years at the time of consent.
- Subject has a BMI ≤ 50 kg/m2.
- Subject has an ASA score of ≤ 3.
- Subject has benign lesion(s) of the rectum or sigmoid colon, such as adenoma (with low- or high-grade dysplasia), neuroendocrine tumor, or other type of polyp as assessed by the most recent colonoscopy/flexible...
- Subject has lesion ≤ 7 cm in size (dimension of greatest extent) and ≤ 75% of the colorectal circumference as assessed by the most recent colonoscopy/flexible sigmoidoscopy.
- Subject is eligible for standard endoscopic submucosal dissection.
- Subject agrees to participate in the study by giving signed informed consent. Preoperative
- Subject anatomy is unsuitable for endoscopic visualization or endoluminal surgery.
- Subject has active left-sided inflammatory bowel disease.
- Subject has an untreated active infection at the time of the procedure.
- Subject is considered part of a vulnerable population (e.g., prisoners, mentally disabled).
- Subject has a severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (e.g., cancer).
- Subject is breastfeeding or pregnant or intends to become pregnant during the study.
- Subject is 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...
- Subject with EF ≤ 45, high cardiac or high pulmonary risk (these people require clearance from a cardiologist and pulmonologist, as applicable).
- Subject on preoperative blood thinners, such as coumadin or heparin, that cannot be weaned prior to surgery.
- Subject is moderately or severely immunocompromised.
- 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. Intraoperative Exclusion Criteria (assessed with third-party...
- Inadequate bowel prep.
- Complex anatomical findings not feasible for an endoluminal approach.
- Anatomical narrowing distal to the lesion site.
- Lesion not located in the rectum or sigmoid colon.
- Lesion size \>7 cm (dimension of greatest extent) or occupies \>75% of the colorectal circumference.
- Lesion demonstrates characteristics indicative of invasive carcinoma, such as failure to lift upon submucosal injection, or any other features that raise the Investigator's suspicion of cancer. Intraoperative Exclusion...
- In the opinion of the Investigator, the subject and/or subject anatomy is not suitable for study device use for any reason.
- Lesion location not accessible by the study device.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Orlando, Florida, United States
- Boston, Massachusetts, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Orlando, Florida, United States; Boston, Massachusetts, United States; Cleveland, Ohio, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.