Migration of ImplantNOTSC-01NCT05899504
The Use of Novel Over-The-Scope-Clip to Prevent Esophageal Stent Migration
A study testing Over-The-Scope-Clip (OTSC) Stent Fix in people with Migration of Implant, run by Asian Institute of Gastroenterology, India.
Trial summary
New endoscopic clipping device called the over-the-scope-clip (OTSC) system (Ovesco Endoscopy, Tübingen, Germany) has become available for the closure of perforations, anastomotic leaks, and fistulas. The OTSC system has a stronger closing force than the through-the-scope hemostatic clip. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Migration of Implant
- What is being tested?
- Over-The-Scope-Clip (OTSC) Stent Fix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Jan 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults (18+ years)
- Have benign, malignant non-stricture esophageal lesions (i.e. fistulae, perforation, leaks) warranting esophageal stent placement as an inpatient or outpatient
- Ability to consent to stent fixation.
Who cannot join
- Patients aged under 18 years of age
- Unable to provide informed consent
- Inherited or acquired coagulopathy likely to affect the risk of bleeding
- Receiving anticoagulant therapy that could not be stopped or bridged prior to procedure
- Breast feeding, pregnant and lactating women's.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Use of Novel Over-The-Scope-Clip to Prevent Esophageal Stent Migration- Randomized Controlled Trial- A Pilot Study
New endoscopic clipping device called the over-the-scope-clip (OTSC) system (Ovesco Endoscopy, Tübingen, Germany) has become available for the closure of perforations, anastomotic leaks, and fistulas. The OTSC system has a stronger closing force than the through-the-scope hemostatic clip. Therefore, some researchers have reported esophageal SEMS fixation with an OTSC to prevent migration.
Read the detailed description
Participants requiring esophageal SEMS placement for various indications such as stricture (benign, malignant), leaks All participants who require esophageal SEMS placement. Esophago-gastroscopy will be done to assess the feasibility of SEMS placement.
Participants are randomized into two arms- one arm (interventional) use of OTSC stent fix after esophageal SEMS placement or the other arm (non-interventional) esophageal SEMS is placed.
Participants are followed up for 1 year to observe stent migration rate in both the groups.
- Conditions
- Migration of Implant
- Being tested
- Over-The-Scope-Clip (OTSC) Stent Fix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Over-The-Scope-Clip (OTSC) Stent FixDevice
A stent that of at least 4 cm longer than the stricture will be used to allow at least a 2-cm extension above and below the proximal and distal tumor margins. The stent positioned over a guidewire and deployed under fluoroscopy guidance and, in some cases, also under endoscopy guidance. Subsequently, the OTSC system will be loaded onto the scope and part of the upper rim of the stent will be suctioned into the transparent cap before releasing the OTSC, grasping both the SEMS and esophageal wall. We will avoid deploying the OTSC in areas of pulsations to prevent potential grasping of the vasculature structure
| Study group | Role | What they receive |
|---|---|---|
| (Interventional) Patients undergoing Esophageal stenting with over the scope clip (OTSC) stent fix | Experimental | Marking clips will be placed with endoscopy at the upper end of the stricture. In mild stricture cases that allowed the passage of the endoscope, marking clips will also placed in the lower end. A stent that of at least 4 cm longer than the stricture will be used to allow at least a 2-cm extension above and below the proximal and distal tumor margins. The stent positioned over a guidewire and deployed under fluoroscopy guidance and, in some cases, also under endoscopy guidance. Subsequently, the OTSC system will be loaded onto the scope and part of the upper rim of the stent will be suctioned into the transparent cap before releasing the OTSC, grasping both the SEMS and esophageal wall. Investigator will avoid deploying the OTSC in areas of pulsations to prevent potential grasping of the vasculature structure. Only a single OTSC will be placed per participants. Receives: Device: Over-The-Scope-Clip (OTSC) Stent Fix |
| (Non- Interventional) Participants undergoing Esophageal stenting without OTSC stent fix | No intervention | This will be the standard procedure of esophageal stent placement under fluro imaging/screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal SEMS migration rate at 4 weeks follow up.
Proportion of patients experiencing stent migration at 4 weeks after index procedure.
Measured: 4 weeks
Secondary outcomes (4)
Procedural time in minutes
Total time required to complete the intended procedure
Measured: immediately after procedure
Migration of stent in both groups
Time to migration after stent placement in respective groups
Measured: 6 months
Adverse events in both groups apart from stent migration
All the adverse events will be recorded, excluding SEMS migration, which is already an primary outcome measure separately
Measured: 6 months
Improvement in dysphagia score
Improvement in dysphagia score at one week post procedure in both the arms
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migration of ImplantStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A new endoscopic clipping device called the over-the-scope-clip (OTSC) system (Ovesco Endoscopy, Tübingen, Germany) has become available for the closure of perforations, anastomotic leaks, and fistulas. The OTSC system has a stronger closing force than the through-the-scope hemostatic clip. Therefore, some researchers have reported esophageal SEMS fixation with an OTSC to prevent migration
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Collaborators
- Ovesco Endoscopy AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899504
- Sponsor's protocol ID
- NOTSC-01
- Acronym
- NOTSC-01
- Status last verified
- Jun 2023
- First submitted
- 29 Jan 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Novel Over-The-Scope-Clip to Prevent Esophageal Stent Migration- Randomized Controlled Trial- A Pilot Study
- ClinicalTrials.gov ID
- NCT05899504
- Acronym / sponsor ID
- NOTSC-01 / NOTSC-01
- Conditions
- Migration of Implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Collaborators
- Ovesco Endoscopy AG
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 12 Jun 2023 (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.
New endoscopic clipping device called the over-the-scope-clip (OTSC) system (Ovesco Endoscopy, Tübingen, Germany) has become available for the closure of perforations, anastomotic leaks, and fistulas. The OTSC system has a stronger closing force than the through-the-scope hemostatic clip. Therefore, some researchers have reported esophageal SEMS fixation with an OTSC to prevent migration.
Detailed description
Participants requiring esophageal SEMS placement for various indications such as stricture (benign, malignant), leaks All participants who require esophageal SEMS placement. Esophago-gastroscopy will be done to assess the feasibility of SEMS placement.
Participants are randomized into two arms- one arm (interventional) use of OTSC stent fix after esophageal SEMS placement or the other arm (non-interventional) esophageal SEMS is placed.
Participants are followed up for 1 year to observe stent migration rate in both the groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A new endoscopic clipping device called the over-the-scope-clip (OTSC) system (Ovesco Endoscopy, Tübingen, Germany) has become available for the closure of perforations, anastomotic leaks, and fistulas. The OTSC system has a stronger closing force than the through-the-scope hemostatic clip. Therefore, some researchers have reported esophageal SEMS fixation with an OTSC to prevent migration
| Arm | Type | Receives |
|---|---|---|
| (Interventional) Patients undergoing Esophageal stenting with over the scope clip (OTSC) stent fix | Experimental | Device: Over-The-Scope-Clip (OTSC) Stent FixMarking clips will be placed with endoscopy at the upper end of the stricture. In mild stricture cases that allowed the passage of the endoscope, marking clips will also placed in the lower end. A stent that of at least 4 cm longer than the stricture will be used to allow at least a 2-cm extension above and below the proximal and distal tumor margins. The stent positioned over a guidewire and deployed under fluoroscopy guidance and, in some cases, also under endoscopy guidance. Subsequently, the OTSC system will be loaded onto the scope and part of the upper rim of the stent will be suctioned into the transparent cap before releasing the OTSC, grasping both the SEMS and esophageal wall. Investigator will avoid deploying the OTSC in areas of pulsations to prevent potential grasping of the vasculature structure. Only a single OTSC will be placed per participants. |
| (Non- Interventional) Participants undergoing Esophageal stenting without OTSC stent fix | No intervention | –This will be the standard procedure of esophageal stent placement under fluro imaging/screening |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All adults (18+ years)
- Have benign, malignant non-stricture esophageal lesions (i.e. fistulae, perforation, leaks) warranting esophageal stent placement as an inpatient or outpatient
- Ability to consent to stent fixation.
Key exclusion criteria (5 listed)
- Patients aged under 18 years of age
- Unable to provide informed consent
- Inherited or acquired coagulopathy likely to affect the risk of bleeding
- Receiving anticoagulant therapy that could not be stopped or bridged prior to procedure
- Breast feeding, pregnant and lactating women's.
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 |
|---|---|---|
| Over-The-Scope-Clip (OTSC) Stent FixA stent that of at least 4 cm longer than the stricture will be used to allow at least a 2-cm extension above and below the proximal and distal tumor margins. The stent positioned over a guidewire and deployed under fluoroscopy guidance and, in some cases, also under endoscopy guidance. Subsequently, the OTSC system will be loaded onto the scope and part of the upper rim of the stent will be suctioned into the transparent cap before releasing the OTSC, grasping both the SEMS and esophageal wall. We will avoid deploying the OTSC in areas of pulsations to prevent potential grasping of the vasculature structure | Device | (Interventional) Patients undergoing Esophageal stenting with over the scope clip (OTSC) stent fix |
Primary outcome
Esophageal SEMS migration rate at 4 weeks follow up.
Time frame: 4 weeks
Proportion of patients experiencing stent migration at 4 weeks after index procedure.
4 secondary outcomes
Procedural time in minutes
Time frame: immediately after procedure
Migration of stent in both groups
Time frame: 6 months
Adverse events in both groups apart from stent migration
Time frame: 6 months
Improvement in dysphagia score
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Over-The-Scope-Clip (OTSC) Stent Fix in people with Migration of Implant, run by Asian Institute of Gastroenterology, India.
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 3 inclusion and 5 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 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Pradev Innovulu, MD (9182645727, pradev32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal SEMS migration rate at 4 weeks follow up. (time frame: 4 weeks). 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 12 Jun 2023.