Refractory Benign StricturesNCT03652285
UAS-RBS: a Safety Study
A study testing Esophageal stent implantation and Stent removal in people with Refractory Benign Strictures, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
A novel stent, called Universal Partially Covered Removable Self-expanding Stent and Anchoring System for the Treatment of Refractory Benign Esophageal Strictures (UAS-RBS) was designed to improve the treatment of benign esophageal refractory strictures with a novel stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Benign Strictures
- What is being tested?
- Esophageal stent implantation and Stent removal
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Mar 2018to 31 Mar 2021
- 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
- Benign Esophageal Refractory Stricture no more than 40 mm in length.
- More than two dilations to at least 16 mm in diameter with symptoms relapse within 6 months.
- Last dilation to 16 mm no more than 6 months before study procedure.
- Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at the time of measurement.
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Who cannot join
- Stricture within 2 cm of the upper esophageal sphincter.
- Dysphagia related to motility disorder.
- Planned adjuvant radiation therapy post esophagectomy.
- Esophageal stent in place.
- Active erosive esophagitis.
- Sensitivity to any components of the stent or delivery system.
- Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
- Currently enrolled in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Universal Partially Covered Removable Self-Expanding Stent and Anchoring System for the Treatment of Refractory Benign Esophageal Strictures (UAS-RBS): a Safety Study
A novel stent, called Universal Partially Covered Removable Self-expanding Stent and Anchoring System for the Treatment of Refractory Benign Esophageal Strictures (UAS-RBS) was designed to improve the treatment of benign esophageal refractory strictures with a novel stent. This study aims at evaluating the safety of this new device.
Read the detailed description
Refractory strictures are defined as benign esophageal strictures who do not achieve acceptable symptom relief despite an intensive dilation schedule. Considering the failure of balloon or mechanical dilation other techniques such as intralesional injection of corticosteroids or stents placement were developed.
Self-expandable metal stents, plastic stents and biodegradable stents are also used in that indication. In a meta-analysis of 18 studies with 444 patients, clinical success was achieved in 41 percent of patients. Stent migration occurred in 29 percent of patients, and adverse events occurred in 21 percent.
A self-expending nitinol stent has been design to reduce the migration risk. The stent is partially covered on both extremities, allowing the formation of small hyperplasia in the middle part of the stent. This design with the inner sheet (usually, when using fully covered stents, the sheet is outside) allows formation of hyperplasia (therefore reducing the risk of migration) but partly controlled by the inner sheet to reduce the risk of lumen occlusion. By this design, the balance between hyperplasia formation to avoid the risk of migration and reducing the risk of lumen occlusion could be entailed stable esophageal calibration.
The UAS-RBS system is a reversible procedure to treat Refractory Benign Esophageal Strictures through stent implantation. Above standard of care monitoring, safety assessment of the procedure and device performance decreases the risk and unforeseen events.
- Conditions
- Refractory Benign Strictures
- Being tested
- Esophageal stent implantation, Stent removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal stent implantationDevice
An upper endoscopy will be performed with the use of fluoroscopy. Depending on the size of the stricture a dilation can be performed prior to the stent deployment. Otherwise, the stent will be deployed over a guidewire, under fluoroscopy.
After, the gastroscopy will go through the esophagus to check for the stent deployment, or any complications.
An injection of contrast agent will be done to be sure of the correct positioning and that no complications was happened.
The patient will be kept overnight, with liquid food for 3 days and under PPI until one month after the stent placement.
Stent removalDevice
Six months after implantation, the removal of the stent will be performed. Patient will undergo a first endoscopy under general anesthesia for the placement of a FCSEMS. Then, depending on the importance of the hyperplasia, removal of both stents, under general anesthesia, will be done after 7 to 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Esophageal stent implantation (UAS-RBS implantation) | Experimental | Esophageal stent implantation (UAS-RBS implantation) at J0, removal after 6 months and follow-up for 6 months Receives: Device: Esophageal stent implantation; Device: Stent removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all Adverse Device Effects
Serious adverse event (SAE) during the period of stent implantation
Measured: 6 months
Technical stent placement success
Ability to deploy the UAS-RBS in satisfactory position across the stricture
Measured: Day 0
Full deployment of stent
Endoscopic visualization
Measured: Day 0
Technical stent removal success
Ability to remove the stent without complications
Measured: up to 6 months
Secondary outcomes (6)
SAE during the period after stent removal
Measured: 6 months post retrieval
Number of re-interventions
Measured: within 12 months following stent placement
Change of dysphagia score (Dakkak and Bennett score of Dysphagia)
Measured: Baseline and at week 1, month 1, 2, 3, 6, 9, 12 after implantation
Patient's satisfaction with the therapy
scored by a visual analog scale (0 worse - 10 best)
Measured: week 1, month 1, 2, 3, 6, 9, 12 after implantation
Patient's report of pain
scored by a visual analog scale (0 worse - 10 best)
Measured: before treatment, and at week 1, month 1, 2, 3, 6, 9, 12 after implantation
Quality Of Life SF36 questionnaire
SF36
Measured: before treatment, and at week 1, month 1, 2, 3, 6, 9, 12 after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start27 Mar 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Benign StricturesStudies of the same condition, open and under way.
- 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
- As a proof of concept, feasibility study - First In Man Study (FIM). The study will enroll 10 patients and an additional 10% of patients to compensate for potential attrition during follow-up, resulting in a sample size of 11 patients.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652285
- Sponsor's protocol ID
- P2017/543
- Status last verified
- Feb 2022
- First submitted
- 10 Jul 2018
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Universal Partially Covered Removable Self-Expanding Stent and Anchoring System for the Treatment of Refractory Benign Esophageal Strictures (UAS-RBS): a Safety Study
- ClinicalTrials.gov ID
- NCT03652285
- Acronym / sponsor ID
- P2017/543
- Conditions
- Refractory Benign Strictures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 29 Aug 2018 (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 novel stent, called Universal Partially Covered Removable Self-expanding Stent and Anchoring System for the Treatment of Refractory Benign Esophageal Strictures (UAS-RBS) was designed to improve the treatment of benign esophageal refractory strictures with a novel stent. This study aims at evaluating the safety of this new device.
Detailed description
Refractory strictures are defined as benign esophageal strictures who do not achieve acceptable symptom relief despite an intensive dilation schedule. Considering the failure of balloon or mechanical dilation other techniques such as intralesional injection of corticosteroids or stents placement were developed.
Self-expandable metal stents, plastic stents and biodegradable stents are also used in that indication. In a meta-analysis of 18 studies with 444 patients, clinical success was achieved in 41 percent of patients. Stent migration occurred in 29 percent of patients, and adverse events occurred in 21 percent.
A self-expending nitinol stent has been design to reduce the migration risk. The stent is partially covered on both extremities, allowing the formation of small hyperplasia in the middle part of the stent. This design with the inner sheet (usually, when using fully covered stents, the sheet is outside) allows formation of hyperplasia (therefore reducing the risk of migration) but partly controlled by the inner sheet to reduce the risk of lumen occlusion. By this design, the balance between hyperplasia formation to avoid the risk of migration and reducing the risk of lumen occlusion could be entailed stable esophageal calibration.
The UAS-RBS system is a reversible procedure to treat Refractory Benign Esophageal Strictures through stent implantation. Above standard of care monitoring, safety assessment of the procedure and device performance decreases the risk and unforeseen events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- As a proof of concept, feasibility study - First In Man Study (FIM). The study will enroll 10 patients and an additional 10% of patients to compensate for potential attrition during follow-up, resulting in a sample size of 11 patients.
| Arm | Type | Receives |
|---|---|---|
| Esophageal stent implantation (UAS-RBS implantation) | Experimental | Device: Esophageal stent implantation, Device: Stent removalEsophageal stent implantation (UAS-RBS implantation) at J0, removal after 6 months and follow-up for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Benign Esophageal Refractory Stricture no more than 40 mm in length.
- More than two dilations to at least 16 mm in diameter with symptoms relapse within 6 months.
- Last dilation to 16 mm no more than 6 months before study procedure.
- Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at the time of measurement.
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Key exclusion criteria (8 listed)
- Stricture within 2 cm of the upper esophageal sphincter.
- Dysphagia related to motility disorder.
- Planned adjuvant radiation therapy post esophagectomy.
- Esophageal stent in place.
- Active erosive esophagitis.
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 |
|---|---|---|
| Esophageal stent implantationAn upper endoscopy will be performed with the use of fluoroscopy. Depending on the size of the stricture a dilation can be performed prior to the stent deployment. Otherwise, the stent will be deployed over a guidewire, under fluoroscopy. After, the gastroscopy will go through the esophagus to check for the stent deployment, or any complications. An injection of contrast agent will be done to be sure of the correct positioning and that no complications was happened. The patient will be kept overnight, with liquid food for 3 days and under PPI until one month after the stent placement. | Device | Esophageal stent implantation (UAS-RBS implantation) |
| Stent removalSix months after implantation, the removal of the stent will be performed. Patient will undergo a first endoscopy under general anesthesia for the placement of a FCSEMS. Then, depending on the importance of the hyperplasia, removal of both stents, under general anesthesia, will be done after 7 to 10 days. | Device | Esophageal stent implantation (UAS-RBS implantation) |
Primary outcome
Incidence of all Adverse Device Effects
Time frame: 6 months
Serious adverse event (SAE) during the period of stent implantation
Technical stent placement success
Time frame: Day 0
Ability to deploy the UAS-RBS in satisfactory position across the stricture
Full deployment of stent
Time frame: Day 0
Endoscopic visualization
Technical stent removal success
Time frame: up to 6 months
Ability to remove the stent without complications
6 secondary outcomes
SAE during the period after stent removal
Time frame: 6 months post retrieval
Number of re-interventions
Time frame: within 12 months following stent placement
Change of dysphagia score (Dakkak and Bennett score of Dysphagia)
Time frame: Baseline and at week 1, month 1, 2, 3, 6, 9, 12 after implantation
Patient's satisfaction with the therapy
Time frame: week 1, month 1, 2, 3, 6, 9, 12 after implantation
Patient's report of pain
Time frame: before treatment, and at week 1, month 1, 2, 3, 6, 9, 12 after implantation
Quality Of Life SF36 questionnaire
Time frame: before treatment, and at week 1, month 1, 2, 3, 6, 9, 12 after implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Refractory Benign Strictures
Recruiting
Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures
Refractory Benign Esophageal Strictures
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal stent implantation and Stent removal in people with Refractory Benign Strictures, run by Erasme University Hospital at 1 site in Belgium.
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 8 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: finished, as of the sponsor's last update on 9 Feb 2022. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all Adverse Device Effects (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2022.