Health TrialsbyHealthPanel

Prospective Study of Using Novel Bipolar Scissors in Colorectal Endoscopic Submucosal Dissection

ConditionsColon PolypColon Neoplasia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChinese University of Hong Kong

About this trial

This study is an interventional, prospective, single-center study to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD in patients with superficial colorectal neoplasia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patient (age ≥18 and ≤80 years-old)

Capability of understanding and complying with the study requirements, including signing the informed consent form.

Patients with colorectal superficial mucosal neoplasia (clinically adenoma or early intramucosal cancer), scheduled to undergo endoscopic submucosal dissection (ESD).

Disqualifiers

Patients unable or unwilling to provide consent.

Patients with lesions unsuitable for ESD, including those suspicious of deep submucosal invasive cancer.

Patients with lesions involving the appendiceal orifice or ileocaecal valve.

Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake monitored anesthesia for the procedure.

Trial design

Design model

Single group

Treatments tested in this trial

  • Colorectal ESD with SpydrBlade Flex

    Device

    The allocated intervention would be performed under sedation or monitored anaesthesia by experienced endoscopists with at least 50 case experience of colon ESD. Colon ESD procedure would be performed as per described in the literature. After submucosal injection of solution to create a cushion, mucosal incision and submucosal dissection would be performed with the SydrBlade Flex. Submucosal plane dissection will be performed using the SpydrBlade Flex (BRF, cutting frequency 400kHz, power setting 35W). The exact resection strategy would be according to the endoscopists' preference, including different adjunctive techniques such as countertraction, tunnelling or pocket creation method. Upon completion of ESD, the resultant mucosal defect would be examined for any perforation or bleeding.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Endoscopic submucosal dissection with SpydrBlade FlexExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

En-bloc resection rate

Defined by complete macroscopic resection of the target neoplasia in one single specimen

Time frame
30 days

Secondary outcomes

1

R0 resection rate

Defined by histologically margin negative resection (Both horizontal and vertical margins)

Time frame
30 days
2

Curative resection rate

Defined by R0 resection and fulfilling existing histological curative resection criteria based on JGES guidelines

Time frame
30 days
3

Adverse event rate

Overall adverse event rate, according to ASGE lexicon

Time frame
30 days
4

Rate of adverse event - hemorrhage

Rate of intraprocedural and post procedural delayed hemorrhage

Time frame
30 days

Other outcomes

1

Procedure time

Duration of ESD

Time frame
1 day
2

Device dysfunction

Failure of device to continue the procedure

Time frame
1 day
3

Need for change to other device

Rate of changing to other ESD knife

Time frame
1 day

Sponsors and contacts

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

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: