Clinical trial · Interventional
TTS Esophageal HILZO Stent: A Safety and Feasibility Study
TTS Esophageal HILZO Covered Self-expandable Metal Stent for Palliation of Malignant Dysphagia: A Safety and Feasibility Study
NCT03269903CI-TRIAL-00029383HILZOunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A multicenter non-randomized prospective clinical study assessing the safety and feasibility of the esophageal through-the-scope HILZO Covered self-expandable metal stent placement for palliation of malignant dysphagia
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophagus Cancer | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HILZO esophageal stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients
- description
- Patients with malignant dysphagia treated with the HILZO stent
- interventionNames
- Device: HILZO esophageal stent
Primary outcomes (3)
- measure
- Incidence of treatment associated adverse events during follow-up (safety)
- timeFrame
- 1 year
- description
- Short term (within 7 days after treatment) and long term (after 7 days) major complications and minor complications. Major complications are defined as life threatening and severe complications such as perforation, haemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening or moderately severe pain and gastroesophageal reflux.
- measure
- Through-the-scope stent placement (feasibility): (1) ease of deployment at intended esophageal location
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Non-operable malignant obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy. A tumor is considered inoperable if the patient has local tumor infiltration in the surrounding organs, distant metastases or a poor general health due to serious concomitant disease. OR * Recurrent dysphagia after prior radiation with curative or palliative intent for esophageal or gastric cardia cancer. * Requiring treatment for dysphagia (dysphagia score of ≥ 2, according to Ogilvie2) * Written informed consent * Age ≥ 18 years Exclusion Criteria: * Inappropriate cultural level and understanding of the study. * Simultaneous participation in another clinical study * Life expectancy of less than 12 months * Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter * Tumor length of more than 12cm * Previous stent placement for the same condition
References
Publications (1)
- DERIVEDVermeulen BD, Reijm AN, van der Bogt RD, van Hooft JE, Spaander MCW, Siersema PD. Through-the-scope placement of a fully covered metal stent for palliation of malignant dysphagia: a prospective cohort study (with video). Gastrointest Endosc. 2019 Dec;90(6):972-979. doi: 10.1016/j.gie.2019.06.030. Epub 2019 Jun 29. PMID 31265819