AchalasiaNCT07406945
Safety and Efficacy of a Novel SpydrBlade Flexible Bipolar in POEM
A study testing SpydrBlade Flex in people with Achalasia and EGJ Outflow Obstruction, run by Chinese University of Hong Kong at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia, EGJ Outflow Obstruction
- What is being tested?
- SpydrBlade Flex
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Nov 2024to 1 Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong
Hong Kong
Hon Chi Yip, +85235052956, hcyip@surgery.cuhk.edu.hk
About this study
Official title: Safety and Efficacy of the Novel SpydrBlade Flex With Radiofrequency and Microwave Ablation Flexible Bipolar for Per-Oral Endoscopic Myotomy in Patients With Achalasia: A Multicenter Prospective Study
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.
Read more
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
- Being tested
- SpydrBlade Flex
- Keywords
- Novel Flexible Bipolar, POEM
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpydrBlade FlexDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SpydrBlade Flex Group | Experimental | Patients will undergo Per-Oral Endoscopic Myotomy (POEM) using the novel SpydrBlade Flex device. Receives: Device: SpydrBlade Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days
Secondary outcomes (5)
Post-Procedural Reflux - Symptom Assessment
Reflux symptoms reported by the patient after the POEM procedure. Patient-reported symptoms tracked during follow-up visits.
Unit of Measure: Presence/absence and description of symptoms (Categorical).
Measured: 30 days
Post-Procedural Reflux - Endoscopic Features
The presence of esophagitis features identified during endoscopic examination. Endoscopic examination performed at postoperative 6 months follow-up.
Unit of Measure: Presence/absence and grading of esophagitis (Categorical).
Measured: 6 months
Post-Procedural Reflux - pH Monitoring
Quantitative assessment of acid reflux. A pH level below 4 for more than 6% of the monitoring period is considered indicative of significant reflux. Measured by the number of patients with significant reflux at postoperative 1 month follow-up divided by total number of patients.
Unit of measure: % of patients
Measured: 30 days
Distensibility of the Lower Esophageal Sphincter (LES)
The distensibility of the LES, an important parameter in Achalasia treatment, will be measured using the EndoFLIP® system during the 6-month follow-up endoscopic examination. It is measured as the Distensibility Index (DI).
Unit of Measure: mm²/mmHg for DI.
Measured: 6 months
Postoperative Northwestern Esophageal Quality of Life questionnaire (NEQOL) score
The NEQOL questionnaire, a tool designed to measure the quality of life specifically in patients with esophageal conditions, will be administered 6 months post-procedure. The NEQOL questionnaire is consisted of 14 questions answered on a 5-point Likert scale, where higher score means a better health-related quality of life (HRQOL).
Unit of Measure: score (0-56)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Nov 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Academy tertiary center, IECED, Guayaquil, Ecuador
- Responsible party
- Principal investigator, Hon Chi Yip, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406945
- Sponsor's protocol ID
- CRE-2024.464
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33654353Oleas 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.
PubMed 36502466Shiu 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.
PubMed 35713453Onimaru 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.
PubMed 33655041Haisley 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.
PubMed 33140317Cappell 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.
PubMed 31451984Su 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.
PubMed 31939098Moran 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.
PubMed 33147642Lundell 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.
PubMed 32919412Mundre 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.
PubMed 33035470Drexel 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.
PubMed 33128887Chadalavada 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.
PubMed 33173323Ahmed 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.
PubMed 31489229Ponds 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.
PubMed 31287522