Safety and Efficacy of a Novel SpydrBlade Flexible Bipolar in POEM

NCT07406945 | Recruiting

• 1 other identifier: CRE-2024.464
• Study Type: interventional
• Target: 73
• Locations: 2 countries
• Sites: 2

Brief Summary

Achalasia is an idiopathic motility disorder, primarily identified by the absence of esophageal peristalsis and the inability of the lower esophageal sphincter (LES) to relax properly. Although it is usually misdiagnosed and treated as gastroesophageal reflux disease (GERD), the main symptom is progressive dysphagia, accompanied by additional symptoms like nocturnal cough, heartburn, weight loss, regurgitation of undigested food and aspiration. The severity of achalasia and the effectiveness of treatments are commonly assessed using the Eckardt Symptom Score (ESS), which evaluates symptoms like weight loss, regurgitation, dysphagia, and retrosternal pain. Diagnosis of achalasia is often delayed, affecting up to 50% of patients. It typically involves a combination of diagnostic tools, such as time barium esophagram (TBE) study, which assesses the movement and clearance of barium in the esophagus; esophagogastroduodenoscopy (EGD), which allows visual examination of the esophagus, stomach, and duodenum; and high-resolution esophageal manometry (HREM), considered the gold standard for achalasia. HREM can also help stratify the condition into different types, influencing treatment choices. Furthermore, the endoluminal functional lumen imaging probe (Endoflip, Crospon Corp, Dangan Galaway, Ireland), which measures baseline parameters of LES, aiding in both diagnosis and treatment evolution. While there is no cure for achalasia, treatments aim to reduce LES pressure. The include pharmacological treatments, such as calcium channel blockers or nitrates; endoscopic treatment, including injection of botulinum toxin in the LES, pneumatic dilation, or per-oral endoscopic myotomy (POEM); and surgical therapies (laparoscopic Heller myotomy). POEM has emerged as a first-line treatment for achalasia due to its minimally invasive nature and high success rates (80%-90%). This technique involves creating a submucosal tunnel and performing myotomy, and it can be performed anteriorly (at 2 o'clock) or posteriorly (at 5 o'clock). The choice between anterior and posterior approaches to POEM often depends on the endoscopist's experience and preference. While current data is inconclusive regarding the superiority of either approach, some suggest that the posterior approach might be technically easier due to procedural characteristics (i.e., alignment between endoscopic accessories and mucosal incision). The introduction to novel technologies with smaller diameters can improve this minimally invasive approach making the procedure more efficient and safer for patients with achalasia. Thus, we aim to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for per-oral endoscopic myotomy in patients with achalasia.

Conditions

Achalasia; EGJ Outflow Obstruction

Keywords

Novel Flexible Bipolar; POEM

Outcome Measures

Primary Outcomes (4)

• Technical Success Rate

  This involves assessing the procedural success of the POEM using the novel bipolar device. Success would typically mean completing the procedure as planned, without technical difficulties or complications. Unit of measure: % of procedures

  1 day

• Clinical Success Rate

  Clinical success rate is defined as the proportion of patients in whom clinical success (as defined by an Eckardt symptom score ≤ 3) is achieved following the procedure. The Eckardt score (range 0-12) will be assessed for each patient before the procedure and at the 1 month postoperative follow-up. Clinical success for an individual patient is defined as achieving a follow-up Eckardt score of 3 or less. The clinical success rate is the percentage of patients who meet this success criterion out of the total analyzed population. Unit of measure: % of patients

  30 days

• [Safety] Incidence of intraoperative complications

  Incidence of adverse events occurring during the procedure, including: perforation, bleeding, infection, and any complications directly related to the device. Unit of measure: % of procedures

  1 day

• [Safety] Incidence of postoperative complications

  Incidence of adverse events occurring within 30 days after the procedure, including: perforation, bleeding, infection, and any complications directly related to the device. Unit of measure: % of procedures

  30 days

Secondary Outcomes (5)

• Post-Procedural Reflux - Symptom Assessment

  30 days

• Post-Procedural Reflux - Endoscopic Features

  6 months

• Post-Procedural Reflux - pH Monitoring

  30 days

• Distensibility of the Lower Esophageal Sphincter (LES)

  6 months

• Postoperative Northwestern Esophageal Quality of Life questionnaire (NEQOL) score

  6 months

Study Arms (1)

SpydrBlade Flex Group

EXPERIMENTAL

Patients will undergo Per-Oral Endoscopic Myotomy (POEM) using the novel SpydrBlade Flex device.

Device: SpydrBlade Flex

Interventions

SpydrBlade Flex DEVICE

The POEM procedure will be performed using the novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK). Both anterior and posterior POEM could be performed, depending on the clinical presentation and endoscopist's preference.

SpydrBlade Flex Group

Eligibility Criteria

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

You may qualify if:

• Patients with 18 years of age or older.
• Patients referred to the participating center with a clinical indication for POEM. This includes conditions such as: achalasia, native or failed Heller myotomy, balloon dilation, and EGJ outflow obstruction.
• Patients who provide informed consent.

You may not qualify if:

• Patients who have contraindications for EGD.
• Patients with an Eckardt score \< 3 before POEM.
• Positive diagnosis of Chagas disease.
• Patients unable to withstand general anesthesia.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Academy tertiary center, IECED, Guayaquil, Ecuador: collaborator

Study Sites (2)

academy tertiary, IECED

Guayaquil, Ecuador

RECRUITING

Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (14)

• Kamal F, Ismail MK, Khan MA, Lee-Smith W, Sharaiha RZ, Sharma S, McDonough S, Tariq R, Marella HK, Khan Z, Heda RP, Tombazzi C, Howden CW, Adler DG. Efficacy and safety of peroral endoscopic myotomy in the management of recurrent achalasia after failed Heller myotomy: a systematic review and meta-analysis. Ann Gastroenterol. 2021;34(2):155-163. doi: 10.20524/aog.2020.0563. Epub 2020 Dec 7.

  PMID: 33654353 BACKGROUND

• Oleas R, Puga-Tejada M, Sanchez-Carriel M, Valero M, Martin-Delgado J, Ospina J, Munoz-Jurado G, Egas-Izquierdo M, Arevalo-Mora M, Alvarado-Escobar H, Pitanga-Lukashok H, Baquerizo-Burgos J, Robles-Medranda C. Spanish translation and validation of a hybrid, health-related quality of life questionnaire for chronic esophageal conditions: NEQOL-S. Neurogastroenterol Motil. 2023 Mar;35(3):e14511. doi: 10.1111/nmo.14511. Epub 2022 Dec 11.

  PMID: 36502466 BACKGROUND

• Shiu SI, Chang CH, Tu YK, Ko CW. The comparisons of different therapeutic modalities for idiopathic achalasia: A systematic review and network meta-analysis. Medicine (Baltimore). 2022 Jun 17;101(24):e29441. doi: 10.1097/MD.0000000000029441.

  PMID: 35713453 BACKGROUND

• Onimaru M, Inoue H, Fujiyoshi Y, Abad MRA, Nishikawa Y, Toshimori A, Shimamura Y, Tanabe M, Sumi K, Ikeda H. Long-term clinical results of per-oral endoscopic myotomy (POEM) for achalasia: First report of more than 10-year patient experience as assessed with a questionnaire-based survey. Endosc Int Open. 2021 Mar;9(3):E409-E416. doi: 10.1055/a-1333-1883. Epub 2021 Feb 19.

  PMID: 33655041 BACKGROUND

• Haisley KR, Swanstrom LL. The Modern Age of POEM: the Past, Present and Future of Per-Oral Endoscopic Myotomy. J Gastrointest Surg. 2021 Feb;25(2):551-557. doi: 10.1007/s11605-020-04815-z. Epub 2020 Nov 2.

  PMID: 33140317 BACKGROUND

• Cappell MS, Stavropoulos SN, Friedel D. Updated Systematic Review of Achalasia, with a Focus on POEM Therapy. Dig Dis Sci. 2020 Jan;65(1):38-65. doi: 10.1007/s10620-019-05784-3. Epub 2019 Aug 27.

  PMID: 31451984 BACKGROUND

• Su B, Callahan ZM, Novak S, Kuchta K, Ujiki MB. Using Impedance Planimetry (EndoFLIP) to Evaluate Myotomy and Predict Outcomes After Surgery for Achalasia. J Gastrointest Surg. 2020 Apr;24(4):964-971. doi: 10.1007/s11605-020-04513-w. Epub 2020 Jan 14.

  PMID: 31939098 BACKGROUND

• Moran RA, Brewer Gutierrez OI, Rahden B, Chang K, Ujiki M, Yoo IK, Gulati S, Romanelli J, Al-Nasser M, Shimizu T, Hedberg MH, Cho JY, Hayee B, Desilets D, Filser J, Fortinsky K, Haji A, Fayad L, Sanaei O, Dbouk M, Kumbhari V, Wolf BJ, Elmunzer BJ, Khashab MA. Impedance planimetry values for predicting clinical response following peroral endoscopic myotomy. Endoscopy. 2021 Jun;53(6):570-577. doi: 10.1055/a-1268-7713. Epub 2020 Nov 4.

  PMID: 33147642 BACKGROUND

• Lundell L. Current and Future Treatment Options in Primary Achalasia. The Role of POEM. J Gastrointestin Liver Dis. 2020 Sep 9;29(3):289-293. doi: 10.15403/jgld-2915. No abstract available.

  PMID: 32919412 BACKGROUND

• Mundre P, Black CJ, Mohammed N, Ford AC. Efficacy of surgical or endoscopic treatment of idiopathic achalasia: a systematic review and network meta-analysis. Lancet Gastroenterol Hepatol. 2021 Jan;6(1):30-38. doi: 10.1016/S2468-1253(20)30296-X. Epub 2020 Oct 6.

  PMID: 33035470 BACKGROUND

• Drexel S, Kishawi S, Marks J. Peroral Esophageal Myotomy. Surg Clin North Am. 2020 Dec;100(6):1183-1192. doi: 10.1016/j.suc.2020.08.004. Epub 2020 Oct 10.

  PMID: 33128887 BACKGROUND

• Chadalavada P, Thota PN, Raja S, Sanaka MR. Peroral Endoscopic Myotomy as a Novel Treatment for Achalasia: Patient Selection and Perspectives. Clin Exp Gastroenterol. 2020 Nov 3;13:485-495. doi: 10.2147/CEG.S230436. eCollection 2020.

  PMID: 33173323 BACKGROUND

• Ahmed Y, Othman MO. Peroral endoscopic myotomy (POEM) for achalasia. J Thorac Dis. 2019 Aug;11(Suppl 12):S1618-S1628. doi: 10.21037/jtd.2019.07.84.

  PMID: 31489229 BACKGROUND

• Ponds FA, Fockens P, Lei A, Neuhaus H, Beyna T, Kandler J, Frieling T, Chiu PWY, Wu JCY, Wong VWY, Costamagna G, Familiari P, Kahrilas PJ, Pandolfino JE, Smout AJPM, Bredenoord AJ. Effect of Peroral Endoscopic Myotomy vs Pneumatic Dilation on Symptom Severity and Treatment Outcomes Among Treatment-Naive Patients With Achalasia: A Randomized Clinical Trial. JAMA. 2019 Jul 9;322(2):134-144. doi: 10.1001/jama.2019.8859.

  PMID: 31287522 BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Hon Chi Yip

CONTACT

+852 3505 2956; hcyip@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1); HK (1)