N/A
Completed N=66
EndoRotor® Endoscopic Mucosal Resection System for the Colon
Polyp of Colon · Endoscopic Mucosal Resection · Recurrent Colon Adenoma
Source: ClinicalTrials.gov NCT04203667 ↗
Enrolled (actual)
66
Serious AEs
10.6%
Results posted
Apr 2022
Primary outcomePrimary: Primary Effectiveness Endpoint Defined as the Ability of the EndoRotor to Resect Lesions Without Concomitant Use of Other Resection Modalities and With no Device-related Serious Adverse Events Through the 90 Day Post Procedure Follow-up Visit. — 45 Participants
Summary
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.
In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Effectiveness Endpoint Defined as the Ability of the EndoRotor to Resect Lesions Without Concomitant Use of Other Resection Modalities and With no Device-related Serious Adverse Events Through the 90 Day Post Procedure Follow-up Visit. |
45 | — |
| PRIMARY Primary Safety Analysis Defined as the Occurrence of Serious Adverse Events Related to the EndoRotor Device as Measured From the Index Procedure Through the 90 Day Post Procedure Follow-up Visit. |
5; 2; 1; 1; 1 | — |
| SECONDARY Efficacy Defined as the Number of Participants Where EndoRotor Was Able to Resect the Entire Lesion in a Single Procedure. |
45 | — |
| SECONDARY Post-resection Stenosis Defined as the Occurrence of Colon Stenosis Following the Index Procedure. |
— | — |
| SECONDARY Rate of Disease Persistence Defined as Remnant Disease at the Location of the Index Resection as Determined Endoscopically by the Investigator at the 90 Day Follow-up Visit. |
21 | — |
| SECONDARY Histologic Assessment Defined as the the Diagnostic Value of the Specimens Collected in the EndoRotor Specimen Trap (Could a Diagnosis be Rendered). |
45 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects aged ≥18 to ≤85 years.
- At least one recurrent flat or sessile colorectal lesion measuring up to 6 cm in diameter and/or length.
- Presence of recurrent flat or sessile lesion where the EndoRotor may be used to resect recurrent neoplasia.
- Favorable anatomy that allows the investigator to access the lesion.
- Subject is able and willing to comply with site standard medical follow-up, including the 90-day follow-up visit.
- Subject has been informed of the nature of the study, agrees to participate and has signed the consent form.
Exclusion Criteria
- Inability to give informed consent.
- Subject age is 85 years of age.
- Presence of a lesion that represents cancer or has a high chance of harboring submucosal invasive cancer.
- Presence of synchronous lesions intended for resection that would require use of a concomitant resection modality
- Medical reasons the procedure cannot be performed (i.e. labile blood pressure, anticoagulation laboratory levels that are too high and risk excessive bleeding, systemic infection, etc.)
- Active antiplatelet therapy (Plavix , 325mg aspirin therapy) - patient off treatment for < 1 week.
- Inability to undergo a procedure under propofol sedation or General Anesthesia.
- Female patients who are known to be pregnant.
- Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g., severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression).
- Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.
- Subject is participating in another study of a device, medication, biologic, or other agent within 90 days and could, in the opinion of the investigator, impact the results of this study.
- Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and participating in evaluations pre- and post-treatment.
Data sourced from ClinicalTrials.gov (NCT04203667). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.