Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

NCT06476678 | Recruiting FDA Device

• 1 other identifier: H-55206
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Both Baylor St Luke's Medical Center and Mayo Scottsdale are considered endoscopic submucosal dissection (ESD) centers of excellence. The investigators at Baylor College of Medicine have previously reported our Esophageal ESD experience using the monopolar current knife. Moreover, the research team have previously reported on the clinical efficacy of the bipolar RFA knife during per-oral endoscopic myotomy (POEM) and colonic ESD. The goal of our study is to prospectively evaluate the efficacy, safety and feasibility of Esophageal ESD using a novel Bipolar-Current ESD device.

Conditions

Esophageal Neoplasm; Esophageal Polyp; Endoscopic Submucosal Dissection; Bipolar Electrocautery

Outcome Measures

Primary Outcomes (1)

• Technical success

  Defined as the ability to perform the entire dissection (procedure) with the novel bipolar knife

  Day 1 (procedure day)

Secondary Outcomes (8)

• Speed of Endoscopic Submucosal Dissection

  During Procedure

• Number of instruments used

  During Procedure

• Rate of muscle injury score

  During Procedure

• Rate of post-electrocautery syndrome

  24 hours, 2 weeks, and 4 weeks

• Change in post-procedural pain score

  24 hours, 2 weeks, and 4 weeks

Study Arms (1)

Treatment arm

Patients who were deemed eligible and signed the consent will undergo the removal of their esophageal precancerous lesion utilizing the novel bipolar knife during their endoscopic submucosal dissection (ESD).

Device: Speedboat™ Ultraslim

Interventions

Speedboat™ Ultraslim DEVICE

Use of Speedboat™ Ultraslim for performing endoscopic submucosal dissection of esophageal lesions.

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing intended ESD of precancerous lesions will be screened by study coordinators for preliminary eligibility and those who meet the inclusion criteria will be approach individually for further discussion about the study and obtaining informed consent.

You may qualify if:

• Patient is \>18 years of age
• Patient can provide informed consent
• Patient is referred for resection of precancerous lesions meeting the following criteria:
• Mucosal based polyp
• Located gastroesophageal junction (GEJ) or proximal to GEJ
• No previous endoscopic resection attempted (EMR or ESD)

You may not qualify if:

• Patients with International Normalized Ratio (INR) \>1.5 or Platelets \<50,000
• Lesions extending past GEJ
• Subepithelial lesions

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Creo Medical Limited: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Salmaan A Jawaid, MD

CONTACT

7137980950; Salmaan.Jawaid@bcm.edu

Haydee Rochits Cueto

CONTACT

7137983606; Haydee.RochitsCueto@bcm.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

US (1)