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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
EndoQuest Robotics, Inc.
Study ID
NCT06133387
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic submucosal dissection using the ELS System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 13, 2025
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    * Subjects with benign final pathology and R0 resection is achieved; or, * Subjects with benign (but not pre-cancerous) final pathology without R0 resection. Subjects in Arm 1 will complete the study after Day 30.
  • Experimental: Arm 2
    * Subjects with final pathology that is upstaged to cancer; or, * Subjects with benign (and pre-cancerous) final pathology without R0 resection. Subjects in Arm 2 will undergo 5-year follow-up to assess long-term oncological outcomes including local recurrence, disease-free survival and overall survival.

Primary Outcome Measure

En Bloc Resection Rate [ Time Frame: On Day 0 (day of procedure) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Mayo ClinicScottsdaleArizona85259
Latasha Bunkley
[email protected]
480-342-5756
Norio Fukami, MD (PRINCIPAL_INVESTIGATOR)
AdventHealthOrlandoFlorida32803
Genevieve Rexford
[email protected]
321-745-5120
Matthew Albert, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115-
Cleveland ClinicClevelandOhio44195
Rita Brienza
[email protected]
216-444-0122
Joshua Sommovilla, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Haydee Rochits Cueto
[email protected]
713-798-3606
Mohamed Othman, MD (PRINCIPAL_INVESTIGATOR)
HCA HealthcareHoustonTexas77004
Jimena Alcocer-Barrios
[email protected]
713-790-0600
Eric Haas, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic· Scottsdale, AZAdventHealth· Orlando, FLBrigham and Women's Hospital· Boston, MACleveland Clinic· Cleveland, OHBaylor College of Medicine· Houston, TXHCA Healthcare· Houston, TX

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