Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBaylor College of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient is >18 years of age

Patient can provide informed consent

Mucosal based polyp

Located gastroesophageal junction (GEJ) or proximal to GEJ

Disqualifiers

Patients with International Normalized Ratio (INR) >1.5 or Platelets <50,000

Lesions extending past GEJ

Subepithelial lesions

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Speedboat™ Ultraslim

    Device

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Treatment arm1 intervention

Trial outcomes

Primary outcomes

1

Technical success

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

Time frame
Day 1 (procedure day)

Secondary outcomes

1

Speed of Endoscopic Submucosal Dissection

The speed of endoscopic submucosal dissection as calculated by cm\^2/hour

Time frame
During Procedure
2

Number of instruments used

Logging the variable equipment utilized during the procedure

Time frame
During Procedure
3

Rate of muscle injury score

As calculated by the Sydney Classification of Deep Mural Injury ranging from Type 0 - Type V with Type V as the most severe score.

Time frame
During Procedure
4

Rate of post-electrocautery syndrome

Define as post-procedure abdominal pain, fevers, leukocytosis

Time frame
24 hours, 2 weeks, and 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor College of Medicine

Lead sponsor

Creo Medical Limited

Collaborator