Blind Loop Syndrome PostoperativeMAGUS-CCSNCT05938439
Evaluation of the Performance of MAgnetic Gastrointestinal Universal Septotome for Treatment of Candy Cane Syndrome
A study testing MAGUS placement in people with Blind Loop Syndrome Postoperative and Candy Cane Syndrome, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Candy cane syndrome (CCS) is an adverse event (AE) from gastrectomy or gastric bypass and end-to-side anastomosis to a jejunal loop. It seems to be predominantly mechanical, the afferent blind loop enlarge and becomes preferential passage of food. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Blind Loop Syndrome Postoperative, Candy Cane Syndrome
- What is being tested?
- MAGUS placement
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is diagnosed with candy cane syndrome based on clinical and endoscopic and/or radiologic assessment
- Patient has at least one of this 3 symptoms associated to CCS: pain, nausea, vomiting, regurgitation
- Patient agrees and is able to comply with the study procedures and provide written informed consent to participate in the study
Who cannot join
- Refractory stenosis of the UGI proximal to the septum
- Septum height smaller than 2 cm or higher than 8 cm
- Coagulation disorders.
- Previous implantation of a magnetic-sensitive medical device (including active electronic implant, metallic stent, …).
- Dysphagia related to motility disorder
- Planned MRI in the following month (30 days) of intervention
Show all 10Show fewer
- Condition that could compromise patient safety
- Patient who went through an abdominal surgery less than 8 weeks before implantation of the magnets
- Patient pregnant, breastfeeding or incapacitated
- Patient currently enrolled in another clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Hôpital Universitaire de Bruxelles - Hôpital Erasme
Brussels, 1070
Pauline Van Ouytsel, MSc., 025556531, pauline.vanouytsel@hubruxelles.be
Secretariat Gastroenterologie Medicale, 025553712, SecMed.GastroMed@erasme.ulb.ac.be
About this study
Candy cane syndrome (CCS) is an adverse event (AE) from gastrectomy or gastric bypass and end-to-side anastomosis to a jejunal loop. It seems to be predominantly mechanical, the afferent blind loop enlarge and becomes preferential passage of food. This food accumulated in the blind loop increase luminal pressure, causing dilatation, early satiety, fullness, pain, reflux, regurgitation, postprandial vomiting, weight loss, and, ultimately, inability to eat, leading to cachexia.Up to now, main treatment is laparoscopic revision which is invasive. Adverse events related this surgical procedure occurred in 13,3% of cases and substantial improvement only in 73.9%.
A first clinical study with MAGUS including oesophageal diverticulum (n=2) and CCS (n=14) has been performed to assess safety and feasibility of this new device. MAGUS is an implantable device which is placed endoscopically and which, by using pressure necrosis, entailed the marsupialization of the blind loop in less than 30 days. Substantial improvement was observed in all patient and only 7,1% of patients experience an adverse event possibly related to the device. This study aim therefore to assess the safety and performance of the endoscopic treatment of CCS using a new medical device: MAGUS.
Read more
This will be a single-center, open-label prospective, safety and performance study on 51 patients with Candy Cane Syndrome (CCS). Patients will be followed for 12 months after the procedure, with an enrolment period of 3 years.
After the screening, the following data will be collected and examinations and tests performed : physical Exam, medical history including CCS cause and treatment(s) history, weight, Eckart and dysphagia score, Quality of Life questionnaire (SF 12 and GERD HRQL), Main symptom selection (Nausea, Vomiting/regurgitation or pain), nausea VAS, vomiting, regurgitation VAS, pain VAS, barium swallow X-ray or endoscopic assessment of Candy Cane. Follow-up visits will be performed at 14 days, 28 days, 3 months and 12 months post-procedure.
- Being tested
- MAGUS placement
- Keywords
- candy cane syndrome, therapeutic endoscopy, steptotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAGUS placementDevice
An upper endoscopy will be performed with the use of fluoroscopy under general anaesthesia with orotracheal intubation. The delivery system will be placed over a guidewire, under fluoroscopy. The main steps are the following:
- Placement through the endoscope of a soft guidewire through the upper GI tract;
- Insertion of the MAGUS system on the guidewire;
- Advancement of the MAGUS system until proximal magnet reach the top of the septum;
- Release and placement of the proximal magnet at the bottom of the septum, pouch side;
- Meeting of the distal and proximal magnet on both sides of the septum, by pulling on the delivery system;
- Release of the distal magnet and activate the retractable wire;
- Insure that wire is not blocked and unblocked it if applicable.
Endoscopy and contrast injection will be performed before and after placement to ensure the correct positioning of the magnets.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | The procedure consists in Medical Device (MAGUS) placement by endoscopy under general anesthesia with fluoroscopic control. Receives: Device: MAGUS placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety related to the number of adverse event
All adverse events device or procedure related will be captured
Measured: During procedure (operative day) ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up
Performance on symptoms evolution
Evolution of pain will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
Measured: At baseline ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up ; at 12 months of follow-up
Performance on symptoms evolution
Evolution of nausea will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
Measured: At baseline ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up ; at 12 months of follow-up
Performance on symptoms evolution
Evolution of regurgitations/vomiting will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
Measured: At baseline ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up ; at 12 months of follow-up
Secondary outcomes (7)
Safety : adverse event at mid and long term
All adverse events will be reported
Measured: After 3 months of implantation
Safety : unplanned interventions
Number of unplanned interventions
Measured: Within the year following device placement
Efficacy : patient's satisfaction with the therapy
Scored by a visual analogue scale from 0 (= not satisfied at all) to 5 (=very satisfied)
Measured: At 3 and 12 months of follow-up
Efficacy : change in quality of life
Short-Form-12 score. A higher score indicates a better quality of life
Measured: At 28 days, 3 months and 12 months of follow-up
Efficacy : dysphagia evolution
Eckart score from 0 to 12. A higher score indicates more severe pathology.
Measured: At 14 and 28 days, and at 3 and 12 months of follow-up
Efficacy : dysphagia evolution
Dysphagia score from 1 to 5. A higher score indicates more severe pathology.
Measured: At 14 and 28 days, and at 3 and 12 months of follow-up
Efficacy : weight evolution
Weight measurment in kg
Measured: At 14 and 28 days, and at 3 and 12 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Aug 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (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 Blind Loop Syndrome PostoperativeStudies 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
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brussel Medical Device Center (BMDC)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938439
- Sponsor's protocol ID
- N2023/021
- Acronym
- MAGUS-CCS
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rio-Tinto R, Huberland F, Van Ouytsel P, Delattre C, Dugardeyn S, Cauche N, Delchambre A, Deviere J, Blero D. Magnet and wire remodeling for the treatment of candy cane syndrome: first case series of a new approach (with video). Gastrointest Endosc. 2022 Jun;95(6):1247-1253. doi: 10.1016/j.gie.2021.12.027. Epub 2022 Jan 1.
PubMed 34979115
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of MAgnetic Gastrointestinal Universal Septotome for Treatment of Candy Cane Syndrome
- ClinicalTrials.gov ID
- NCT05938439
- Acronym / sponsor ID
- MAGUS-CCS / N2023/021
- Keywords
- candy cane syndrome, therapeutic endoscopy, steptotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Brussel Medical Device Center (BMDC)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 10 Jul 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.
Candy cane syndrome (CCS) is an adverse event (AE) from gastrectomy or gastric bypass and end-to-side anastomosis to a jejunal loop. It seems to be predominantly mechanical, the afferent blind loop enlarge and becomes preferential passage of food. This food accumulated in the blind loop increase luminal pressure, causing dilatation, early satiety, fullness, pain, reflux, regurgitation, postprandial vomiting, weight loss, and, ultimately, inability to eat, leading to cachexia.Up to now, main treatment is laparoscopic revision which is invasive. Adverse events related this surgical procedure occurred in 13,3% of cases and substantial improvement only in 73.9%.
A first clinical study with MAGUS including oesophageal diverticulum (n=2) and CCS (n=14) has been performed to assess safety and feasibility of this new device. MAGUS is an implantable device which is placed endoscopically and which, by using pressure necrosis, entailed the marsupialization of the blind loop in less than 30 days. Substantial improvement was observed in all patient and only 7,1% of patients experience an adverse event possibly related to the device. This study aim therefore to assess the safety and performance of the endoscopic treatment of CCS using a new medical device: MAGUS.
This will be a single-center, open-label prospective, safety and performance study on 51 patients with Candy Cane Syndrome (CCS). Patients will be followed for 12 months after the procedure, with an enrolment period of 3 years.
After the screening, the following data will be collected and examinations and tests performed : physical Exam, medical history including CCS cause and treatment(s) history, weight, Eckart and dysphagia score, Quality of Life questionnaire (SF 12 and GERD HRQL), Main symptom selection (Nausea, Vomiting/regurgitation or pain), nausea VAS, vomiting, regurgitation VAS, pain VAS, barium swallow X-ray or endoscopic assessment of Candy Cane. Follow-up visits will be performed at 14 days, 28 days, 3 months and 12 months post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: MAGUS placementThe procedure consists in Medical Device (MAGUS) placement by endoscopy under general anesthesia with fluoroscopic control. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is diagnosed with candy cane syndrome based on clinical and endoscopic and/or radiologic assessment
- Patient has at least one of this 3 symptoms associated to CCS: pain, nausea, vomiting, regurgitation
- Patient agrees and is able to comply with the study procedures and provide written informed consent to participate in the study
Key exclusion criteria (10 listed)
- Refractory stenosis of the UGI proximal to the septum
- Septum height smaller than 2 cm or higher than 8 cm
- Coagulation disorders.
- Dysphagia related to motility disorder
- Planned MRI in the following month (30 days) of intervention
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 |
|---|---|---|
| MAGUS placementAn upper endoscopy will be performed with the use of fluoroscopy under general anaesthesia with orotracheal intubation. The delivery system will be placed over a guidewire, under fluoroscopy. The main steps are the following: * Placement through the endoscope of a soft guidewire through the upper GI tract; * Insertion of the MAGUS system on the guidewire; * Advancement of the MAGUS system until proximal magnet reach the top of the septum; * Release and placement of the proximal magnet at the bottom of the septum, pouch side; * Meeting of the distal and proximal magnet on both sides of the septum, by pulling on the delivery system; * Release of the distal magnet and activate the retractable wire; * Insure that wire is not blocked and unblocked it if applicable. Endoscopy and contrast injection will be performed before and after placement to ensure the correct positioning of the magnets. | Device | Interventional |
Primary outcome
Safety related to the number of adverse event
Time frame: During procedure (operative day) ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up
All adverse events device or procedure related will be captured
Performance on symptoms evolution
Time frame: At baseline ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up ; at 12 months of follow-up
Evolution of pain will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
Performance on symptoms evolution
Time frame: At baseline ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up ; at 12 months of follow-up
Evolution of nausea will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
Performance on symptoms evolution
Time frame: At baseline ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up ; at 12 months of follow-up
Evolution of regurgitations/vomiting will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
7 secondary outcomes
Safety : adverse event at mid and long term
Time frame: After 3 months of implantation
Safety : unplanned interventions
Time frame: Within the year following device placement
Efficacy : patient's satisfaction with the therapy
Time frame: At 3 and 12 months of follow-up
Efficacy : change in quality of life
Time frame: At 28 days, 3 months and 12 months of follow-up
Efficacy : dysphagia evolution
Time frame: At 14 and 28 days, and at 3 and 12 months of follow-up
Efficacy : dysphagia evolution
Time frame: At 14 and 28 days, and at 3 and 12 months of follow-up
Efficacy : weight evolution
Time frame: At 14 and 28 days, and at 3 and 12 months of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 34979115Rio-Tinto R, Huberland F, Van Ouytsel P, Delattre C, Dugardeyn S, Cauche N, Delchambre A, Deviere J, Blero D. Magnet and wire remodeling for the treatment of candy cane syndrome: first case series of a new approach (with video). Gastrointest Endosc. 2022 Jun;95(6):1247-1253. doi: 10.1016/j.gie.2021.12.027. Epub 2022 Jan 1.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAGUS placement in people with Blind Loop Syndrome Postoperative and Candy Cane Syndrome, 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 18 Nov 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pauline Van Ouytsel (025556531, pauline.vanouytsel@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety related to the number of adverse event (time frame: During procedure (operative day) ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up). 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?
On the ClinicalTrials.gov record for NCT05938439, 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 18 Nov 2023.