Esophagus CancerHILZONCT03269903
TTS Esophageal HILZO Stent: A Safety and Feasibility Study
A study testing HILZO esophageal stent in people with Esophagus Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- HILZO esophageal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2017to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6500HB
Bram Vermeulen, Drs., 0031611079557, bram.vermeulen@radboudumc.nl
About this study
Official title: TTS Esophageal HILZO Covered Self-expandable Metal Stent for Palliation of Malignant Dysphagia: A Safety and Feasibility Study
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
Read the detailed description
The main objective of this study is to evaluate the safety and efficacy of placement of the esophageal HILZO Covered stent with the TTS method in patients with non-operable malignant obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy.
Other (secondary) objects are to assess the effect of the stent on the presence of hyperplastic reaction after implantation, the functional complications and survival.
- Conditions
- Esophagus Cancer
- Being tested
- HILZO esophageal stent
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HILZO esophageal stentDevice
A fully covered esophageal self-expandable metal stent for malignant dysphagia
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients with malignant dysphagia treated with the HILZO stent Receives: Device: HILZO esophageal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment associated adverse events during follow-up (safety)
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.
Measured: 1 year
Through-the-scope stent placement (feasibility): (1) ease of deployment at intended esophageal location
Technical success is defined as ease of through-the-scope deployment and placement of the stent at the required esophageal location.
Measured: 1 day
Through-the-scope stent placement (feasibility): incidence of device related adverse device events at moment of stent placement
Device related adverse events are defined as all adverse events that take place during the through-the-scope stent placement. The incidence of the device related adverse events will be recorded.
Measured: 1 day
Secondary outcomes (2)
Dysphagia, measured with the Ogilvie Dysphagia score (functional outcome)
Ogilvie dysphagia score measured at: baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up.
Measured: 6 months
Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale (functional outcome)
Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale. Measurements will take place at 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up
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 posted1 Sep 2017
- Study start1 Mar 2017
- Primary completion1 Mar 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Model description
- Multicenter non-randomized prospective clinical study in 30 patients with malignant dysphagia
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kebomed B.V.
- Responsible party
- Sponsor
- Investigators
- Peter Siersema, professor, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269903
- Sponsor's protocol ID
- NL.59951.091.16
- Acronym
- HILZO
- Status last verified
- May 2017
- First submitted
- 29 May 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vermeulen 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.
PubMed 31265819
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TTS Esophageal HILZO Covered Self-expandable Metal Stent for Palliation of Malignant Dysphagia: A Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT03269903
- Acronym / sponsor ID
- HILZO / NL.59951.091.16
- Conditions
- Esophagus Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Kebomed B.V.
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The main objective of this study is to evaluate the safety and efficacy of placement of the esophageal HILZO Covered stent with the TTS method in patients with non-operable malignant obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy.
Other (secondary) objects are to assess the effect of the stent on the presence of hyperplastic reaction after implantation, the functional complications and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter non-randomized prospective clinical study in 30 patients with malignant dysphagia
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: HILZO esophageal stentPatients with malignant dysphagia treated with the HILZO stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HILZO esophageal stentA fully covered esophageal self-expandable metal stent for malignant dysphagia | Device | Patients |
Primary outcome
Incidence of treatment associated adverse events during follow-up (safety)
Time frame: 1 year
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.
Through-the-scope stent placement (feasibility): (1) ease of deployment at intended esophageal location
Time frame: 1 day
Technical success is defined as ease of through-the-scope deployment and placement of the stent at the required esophageal location.
Through-the-scope stent placement (feasibility): incidence of device related adverse device events at moment of stent placement
Time frame: 1 day
Device related adverse events are defined as all adverse events that take place during the through-the-scope stent placement. The incidence of the device related adverse events will be recorded.
2 secondary outcomes
Dysphagia, measured with the Ogilvie Dysphagia score (functional outcome)
Time frame: 6 months
Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale (functional outcome)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Derived from this study: PubMed 31265819Vermeulen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Siersema, professor principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HILZO esophageal stent in people with Esophagus Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bram Vermeulen, Drs. (0031611079557, bram.vermeulen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment associated adverse events during follow-up (safety) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03269903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.