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PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System

NCT06133387 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-04-14

No results posted yet for this study

Summary

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.

The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge and Days 7 and 30.

Conditions

  • Colorectal Lesion
  • Colorectal Adenoma
  • Colorectal Polyp
  • Rectal Lesion
  • Rectal Adenoma
  • Rectal Polyp
  • Sigmoid; Lesion
  • Sigmoid Colon Polyp

Interventions

DEVICE

Endoscopic submucosal dissection using the ELS System

All subjects will undergo endoscopic submucosal dissection, with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon.

Sponsors & Collaborators

  • EndoQuest Robotics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-13
Primary Completion
2026-05-31
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06133387 on ClinicalTrials.gov