Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06476678

Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Haydee Rochits Cueto

CONTACT

[email protected]

7137983606

Mohamed Othman, MD

SUB_INVESTIGATOR

Salmaan Jawaid, MD

CONTACT

[email protected]

713-798-0950

Salmaan Jawaid, MD

PRINCIPAL_INVESTIGATOR

Tara Keihanian, MD

SUB_INVESTIGATOR

About this study

Endoscopic submucosal dissection (ESD) is a novel technique for the removal of esophageal lesions or polyps with high-risk features. ESD is minimally invasive and allows the removal of esophageal polyps without resorting to morbid surgery. The process of ESD includes marking the lesions selected for removal, followed by submucosal injection of a lifting agent, then circumferential incisions using a specialized knife followed by submucosal dissection of the entire lesion.

Traditionally, knifes utilizing monopolar current were the preferred tools for endoscopic submucosal dissection. These knifes allow accurate dissection and excellent hemostasis. However, due to monopolar current generated heat, post coagulation syndrome can be seen in up to 8 to 40 % of patients. Post coagulation syndrome present with pain, fever and leukocytosis and requires supportive treatment with IV fluid and antibiotics. In addition, for large esophageal lesions, stricturing can occur after resection due to significant scar formation resulting from the tissue healing response to electrocautery. Almost all patients with >60% of the esophageal circumference removed via monopolar knives, will develop an esophageal stricture at some point. These patients require serial esophageal dilations, and although easily managed, its development can be quite troublesome to the patient. Nevertheless, ESD is still the preferred modality for removal of these lesions since it avoids the need for morbid surgery.

Recently, a novel Bipolar RFA knife was FDA approved for endoscopic submucosal dissection. The low voltage bipolar system allows for precise cutting of submucosa and muscle using substantially less energy, thereby limiting inadvertent remote thermal effects. Additionally, it allows aggressive coagulation of vessels without dissipation of large amounts of energy, thereby allowing more targeted therapy. Moreover, with the addition of an integrated injection needle, the knife now allows injection, safe cutting and coagulation in one device, potentially supporting more efficient dissection. Ultimately, due to less thermal effect on surrounding tissue, the bipolar knife may allow for removal of large esophageal lesions without causing major esophageal stricturing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

Speedboat™ Ultraslim

Device

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

Primary outcomes

  1. Technical success

    Time frame: Day 1 (procedure day)

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

Secondary outcomes

  1. Speed of Endoscopic Submucosal Dissection

    Time frame: During Procedure

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

  2. Number of instruments used

    Time frame: During Procedure

    Logging the variable equipment utilized during the procedure

  3. Rate of muscle injury score

    Time frame: During Procedure

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

  4. Rate of post-electrocautery syndrome

    Time frame: 24 hours, 2 weeks, and 4 weeks

    Define as post-procedure abdominal pain, fevers, leukocytosis

  5. Change in post-procedural pain score

    Time frame: 24 hours, 2 weeks, and 4 weeks

    As calculated by the visual analog pain scale to measure patient pain ranging from 0-10 with 10 being the most pain.

  6. Rate of esophageal stricturing

    Time frame: Assessed at any follow-up post-procedure endoscopies up to 6 months

    Calculated by number of documented occurrences post-procedure for subjects

  7. Degree of scar formation

    Time frame: Assessed at any follow-up post-procedure endoscopies up to 6 months

    Scar formation that occurs in response to electrocautery

  8. Cost of dissection

    Time frame: During Procedure

    As calculated upon review of devices used during dissection procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Haydee Rochits Cueto

CONTACT

[email protected]

7137983606

Salmaan A Jawaid, MD

CONTACT

[email protected]

7137980950

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Creo Medical Limited

Registry information

Official study title

Prospective Multicenter Trial Evaluating the Efficacy and Feasibility of a Novel Bipolar Radiofrequency Ablation Knife in Esophageal Endoscopic Submucosal Dissection

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2024
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.