Small Bowel DiseaseMOTOR-AIG-01NCT05548140
Novel Motorized Spiral Enteroscopy Vs Single Balloon Enteroscopy In Patients With Small Bowel Disorders- A RCT
A study testing Novel Motorized Spiral Enteroscopy in people with Small Bowel Disease, run by Asian Institute of Gastroenterology, India at 2 sites in India.
Trial summary
STUDY OBJECTIVES: 1. Primary objective: Rate of total enteroscopy (TER) by means of NMSE or SBE with: Complete antegrade approach or combined antegrade and retrograde approach 2. Secondary objective: 1. Technical success of anterograde and retrograde approach 2. Procedural time (minutes) 3. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Small Bowel Disease
- What is being tested?
- Novel Motorized Spiral Enteroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesIndia
- Study dates
- 20 Sep 2022to 15 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with small bowel disease with an indication for total enteroscopy with indeterminate imaging findings (as defined above)
- Age > 18 years
- Patients willing to give written consent
Who cannot join
- Positive imaging findings (as defined)
- Age < 18 years.
- Contraindications for endoscopy due to comorbidities
- Unable to provide written informed consent
- Patients with known severe GI tract inflammation, intestinal obstruction, gastroesophageal varices that preclude a safe enteroscopy procedure
- Coagulopathy or thrombocytopenia that couldn't be corrected by blood product transfusion
Show all 11Show fewer
- Pregnant patients
- Health status American Society of Anaesthetist Classification (ASA) >3
- Inability to tolerate sedation or general anaesthesia for any reason
- Pediatrics patients (infants and toddlers)
- Eosinophilic esophagitis
Trial locations and contacts
2 sites in 1 country.
India2 sites
Hardik Rughwani
Hyderabad, Other, 500032
AIG Hospitals
Hyderabad, Telangana, 500032
About this study
Official title: Novel Motorized Spiral Enteroscopy Vs Single Balloon Enteroscopy In Patients With Small Bowel Disorders- A Randomized Controlled Trial
STUDY OBJECTIVES:
- Primary objective: Rate of total enteroscopy (TER) by means of NMSE or SBE with: Complete antegrade approach or combined antegrade and retrograde approach
- Secondary objective:
- Technical success of anterograde and retrograde approach
- Procedural time (minutes)
- Depth of maximum insertion (cm)
- Diagnostic yield
- Therapeutic success
- Adverse events
Read the detailed description
- INTRODUCTION: Small-bowel (SB) disorders remain a diagnostic and therapeutic challenge for endoscopists because of its unfavourable anatomy for endoscopy. It is difficult to perform deep enteroscopy of the long redundant lengthy small intestine by the bare endoscope, most of the time operator end up in pushing the SB rather than traveling through it. Last two decades saw a paradigm shift in the management of SB disorders with the introduction of deep enteroscopy1-4, including Double-balloon enteroscopy (DBE, Fujifilm, Tokyo, Japan), Single-balloon enteroscopy5 (SBE, Olympus Medical Systems Corporation, Tokyo, Japan), and Spiral enteroscopy6 (SE, Spiral Medical, LCC, USA). The DBE and SBE techniques have had varied results as far as depth of insertion is concerned; moreover, both are time-consuming and have difficult ergonomics for the endoscopist which are a major limiting factor. Spiral enteroscopy (SE)6 was introduced in 2007, which was two-operator technique where a spiral-shaped over-tube (Discovery Small Bowel, DSB) was used to pleat the small bowel over the enteroscope by manual rotation of the over tube. Deep endoscopic access to the small bowel with all available methods is still a complex, cumbersome, time-consuming procedure, and requires high endoscopic skills. Novel Motorized Spiral Enteroscope7 (NMSE, Olympus Medical, Tokyo, Japan) is a recent advancement in the field of enteroscopy. This enteroscope works on the same principle as that of SE and comes with an integrated user controlled motor in the handle of the enteroscope. The integrated electric motor is controlled with the help of a footswitch for rotating a short spiral over tube to pleat and un-pleat the small bowel. This would increase the possibility to accelerate the procedure, facilitate insertion, and simplify the technique with a single operator. The procedure can be done both by antegrade and retrograde approaches. Data is scarce on the utility, safety and efficacy of Novel Motorized Spiral Enteroscopy (NMSE) for evaluation in patients with suspected SBD by both the routes of examination. Also there are no comparative studies between SBE and NMSE. Hence we have planned a Randomized controlled trial to compare both modalities.
- RATIONALE: SBE is the standard procedure used for small bowel examination at our center. SBE in prior studies has shown diagnostic yield of 40-60%5 but very low TER (0-22%)4,10, with long procedure time. NMSE on the other hand has the advantage of greater TER and high diagnostic yield with shorter procedure times and minimal adverse events. Our study on NMSE11 has shown high diagnostic yield of 70%, with TER of 61% and total procedure time of around 40min. Various studies have shown the safety and efficacy of SBE and NMSE. One recent prospective study by Beyna9 et al. using NMSE for only antegrade enteroscopy showed total enteroscopy rate (TER) of 10.6% (14/132) with technical success of 97%. Majority of patients (74.2%) underwent NMSE for suspected GI bleeding. Overall diagnostic yield was 74.2% and endotherapy was done in 68.2% patients. In our study11 on NMSE, recently published, we have shown comparable technical success using both antegrade (92.85%) and retrograde (100%) routes. There was higher total enteroscopy rate of 60.6% with antegrade route showing 31.1%.This real-world scenario analysis showed that diagnostic yield of NMSE was 70% in those who successfully underwent enteroscopy and therapeutic procedures were done in almost one fourth of patients. Till date, there are no comparative data between NMSE and Balloon assisted enteroscopy techniques. Hence, we aim to compare NMSE and SBE in Randomized controlled trial.
- STUDY METHODS / STUDY PROCEDURE / METHODS OF ASSESSMENT: Patients presenting with symptoms and signs suggestive of small bowel disorders will be admitted and investigated as per the latest guidelines2. Patients satisfying the inclusion and exclusion criteria will be randomized in one of the two arms and will undergo either NMSE or SBE. As per the presentation and indication patients in both arms will undergo antegrade or retrograde enteroscopy. Patients undergoing antegrade enteroscopy will also undergo retrograde enteroscopy if indicated in the same sitting with the aim of total enteroscopy. Patients will be managed according to the findings and will be discharged as per the conditions. Patients will be followed up in the OPD or telephonically 1 week and after 1 month of discharge.
- Conditions
- Small Bowel Disease
- Being tested
- Novel Motorized Spiral Enteroscopy
- Keywords
- Small bowel disease, IBD, Single balloon enteroscopy, spiral enteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Motorized Spiral EnteroscopyDevice
Also called Single Balloon Enteroscopy
This study involves performance of spiral enteroscopy in one arm and single balloon enteroscopy in the other arm in patients who satisfy inclusion criteria
| Study group | Role | What they receive |
|---|---|---|
| NOVEL MOTORIZED SPIRAL ENTEROSCOPY | Experimental | This arm involves performance of spiral enteroscopy using a specialized enteroscope under general anaesthesia in patients who fulfill the inclusion criteria. Receives: Device: Novel Motorized Spiral Enteroscopy |
| SINGLE BALLOON ENTEROSCOPY | Active comparator | This arm involves performance of single balloon enteroscopy using a specialized single balloon enteroscope in patients who fulfill inclusion criteria. Receives: Device: Novel Motorized Spiral Enteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of total enteroscopy (TER)
Number of cases in which total small bowel examination can be performed
Measured: 1 year
Secondary outcomes (6)
Technical success of anterograde and retrograde approach
For anterograde approach, crossing of duodenal-jejunal flexure and for retrograde approach, crossing of ileo-caecal valve- describes technical success
Measured: 1 year
Procedural time (minutes)
Time taken for the entire procedure from start to end is procedural time
Measured: 1 year
Depth of maximum insertion (cm)
The depth till which the small bowel examination can be done. The examination can be done till we reach the expected lesion or till the scope stops further movement in small intestines
Measured: 1 year
Diagnostic yield
Diagnostic yield is defined as the percentage of procedures that can either confirm a diagnosis from previous studies or established a new definitive diagnosis at the anatomic location identified in previous studies or findings that could explain the clinical symptoms.
Measured: 1 year
Therapeutic success
Therapeutic success is defined as successful endoscopic interventions such as for GI bleeding, polypectomy, and so on.
Measured: 1 year
Adverse events
Adverse events are defined as minor or major. Minor adverse event was defined as superficial esophageal or colonic trauma, sore throat less than 72 hours in duration, abdominal discomfort lasting less than 48 hours, and mild nausea or vomiting not requiring hospital admission. Major adverse events were defined as perforation, significant bleeding requiring blood products, pancreatitis, or any hospital admission related to the procedure.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start20 Sep 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Small Bowel DiseaseStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Dr Hardik Rughwani, MBBS, MD, DM, Principal investigator, AIG Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548140
- Sponsor's protocol ID
- MOTOR-AIG-01
- Acronym
- MOTOR-AIG-01
- Status last verified
- Mar 2023
- First submitted
- 25 May 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramchandani M, Rughwani H, Inavolu P, Singh AP, Tevethia HV, Jagtap N, Sekaran A, Kanakagiri H, Darishetty S, Reddy DN. Diagnostic yield and therapeutic impact of novel motorized spiral enteroscopy in small-bowel disorders: a single-center, real-world experience from a tertiary care hospital (with video). Gastrointest Endosc. 2021 Mar;93(3):616-626. doi: 10.1016/j.gie.2020.07.001. Epub 2020 Jul 12.
PubMed 32663489Rondonotti E, Spada C, Adler S, May A, Despott EJ, Koulaouzidis A, Panter S, Domagk D, Fernandez-Urien I, Rahmi G, Riccioni ME, van Hooft JE, Hassan C, Pennazio M. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2018 Apr;50(4):423-446. doi: 10.1055/a-0576-0566. Epub 2018 Mar 14.
PubMed 29539652Buscaglia JM, Dunbar KB, Okolo PI 3rd, Judah J, Akerman PA, Cantero D, Draganov PV. The spiral enteroscopy training initiative: results of a prospective study evaluating the Discovery SB overtube device during small bowel enteroscopy (with video). Endoscopy. 2009 Mar;41(3):194-9. doi: 10.1055/s-0028-1119602. Epub 2009 Mar 11.
PubMed 19280530Yamamoto H, Ogata H, Matsumoto T, Ohmiya N, Ohtsuka K, Watanabe K, Yano T, Matsui T, Higuchi K, Nakamura T, Fujimoto K. Clinical Practice Guideline for Enteroscopy. Dig Endosc. 2017 Jul;29(5):519-546. doi: 10.1111/den.12883. Epub 2017 Jun 9.
PubMed 28370422
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Motorized Spiral Enteroscopy Vs Single Balloon Enteroscopy In Patients With Small Bowel Disorders- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05548140
- Acronym / sponsor ID
- MOTOR-AIG-01 / MOTOR-AIG-01
- Conditions
- Small Bowel Disease
- Keywords
- Small bowel disease, IBD, Single balloon enteroscopy, spiral enteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 21 Sep 2022 (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.
STUDY OBJECTIVES:
- Primary objective: Rate of total enteroscopy (TER) by means of NMSE or SBE with: Complete antegrade approach or combined antegrade and retrograde approach
- Secondary objective:
- Technical success of anterograde and retrograde approach
- Procedural time (minutes)
- Depth of maximum insertion (cm)
- Diagnostic yield
- Therapeutic success
- Adverse events
Detailed description
- INTRODUCTION: Small-bowel (SB) disorders remain a diagnostic and therapeutic challenge for endoscopists because of its unfavourable anatomy for endoscopy. It is difficult to perform deep enteroscopy of the long redundant lengthy small intestine by the bare endoscope, most of the time operator end up in pushing the SB rather than traveling through it. Last two decades saw a paradigm shift in the management of SB disorders with the introduction of deep enteroscopy1-4, including Double-balloon enteroscopy (DBE, Fujifilm, Tokyo, Japan), Single-balloon enteroscopy5 (SBE, Olympus Medical Systems Corporation, Tokyo, Japan), and Spiral enteroscopy6 (SE, Spiral Medical, LCC, USA). The DBE and SBE techniques have had varied results as far as depth of insertion is concerned; moreover, both are time-consuming and have difficult ergonomics for the endoscopist which are a major limiting factor. Spiral enteroscopy (SE)6 was introduced in 2007, which was two-operator technique where a spiral-shaped over-tube (Discovery Small Bowel, DSB) was used to pleat the small bowel over the enteroscope by manual rotation of the over tube. Deep endoscopic access to the small bowel with all available methods is still a complex, cumbersome, time-consuming procedure, and requires high endoscopic skills. Novel Motorized Spiral Enteroscope7 (NMSE, Olympus Medical, Tokyo, Japan) is a recent advancement in the field of enteroscopy. This enteroscope works on the same principle as that of SE and comes with an integrated user controlled motor in the handle of the enteroscope. The integrated electric motor is controlled with the help of a footswitch for rotating a short spiral over tube to pleat and un-pleat the small bowel. This would increase the possibility to accelerate the procedure, facilitate insertion, and simplify the technique with a single operator. The procedure can be done both by antegrade and retrograde approaches. Data is scarce on the utility, safety and efficacy of Novel Motorized Spiral Enteroscopy (NMSE) for evaluation in patients with suspected SBD by both the routes of examination. Also there are no comparative studies between SBE and NMSE. Hence we have planned a Randomized controlled trial to compare both modalities.
- RATIONALE: SBE is the standard procedure used for small bowel examination at our center. SBE in prior studies has shown diagnostic yield of 40-60%5 but very low TER (0-22%)4,10, with long procedure time. NMSE on the other hand has the advantage of greater TER and high diagnostic yield with shorter procedure times and minimal adverse events. Our study on NMSE11 has shown high diagnostic yield of 70%, with TER of 61% and total procedure time of around 40min. Various studies have shown the safety and efficacy of SBE and NMSE. One recent prospective study by Beyna9 et al. using NMSE for only antegrade enteroscopy showed total enteroscopy rate (TER) of 10.6% (14/132) with technical success of 97%. Majority of patients (74.2%) underwent NMSE for suspected GI bleeding. Overall diagnostic yield was 74.2% and endotherapy was done in 68.2% patients. In our study11 on NMSE, recently published, we have shown comparable technical success using both antegrade (92.85%) and retrograde (100%) routes. There was higher total enteroscopy rate of 60.6% with antegrade route showing 31.1%.This real-world scenario analysis showed that diagnostic yield of NMSE was 70% in those who successfully underwent enteroscopy and therapeutic procedures were done in almost one fourth of patients. Till date, there are no comparative data between NMSE and Balloon assisted enteroscopy techniques. Hence, we aim to compare NMSE and SBE in Randomized controlled trial.
- STUDY METHODS / STUDY PROCEDURE / METHODS OF ASSESSMENT: Patients presenting with symptoms and signs suggestive of small bowel disorders will be admitted and investigated as per the latest guidelines2. Patients satisfying the inclusion and exclusion criteria will be randomized in one of the two arms and will undergo either NMSE or SBE. As per the presentation and indication patients in both arms will undergo antegrade or retrograde enteroscopy. Patients undergoing antegrade enteroscopy will also undergo retrograde enteroscopy if indicated in the same sitting with the aim of total enteroscopy. Patients will be managed according to the findings and will be discharged as per the conditions. Patients will be followed up in the OPD or telephonically 1 week and after 1 month of discharge.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOVEL MOTORIZED SPIRAL ENTEROSCOPY | Experimental | Device: Novel Motorized Spiral EnteroscopyThis arm involves performance of spiral enteroscopy using a specialized enteroscope under general anaesthesia in patients who fulfill the inclusion criteria. |
| SINGLE BALLOON ENTEROSCOPY | Active comparator | Device: Novel Motorized Spiral EnteroscopyThis arm involves performance of single balloon enteroscopy using a specialized single balloon enteroscope in patients who fulfill inclusion criteria. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with small bowel disease with an indication for total enteroscopy with indeterminate imaging findings (as defined above)
- Age > 18 years
- Patients willing to give written consent
Key exclusion criteria (11 listed)
- Positive imaging findings (as defined)
- Age < 18 years.
- Contraindications for endoscopy due to comorbidities
- Unable to provide written informed consent
- Patients with known severe GI tract inflammation, intestinal obstruction, gastroesophageal varices that preclude a safe enteroscopy procedure
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 |
|---|---|---|
| Novel Motorized Spiral EnteroscopyAlso: Single Balloon EnteroscopyThis study involves performance of spiral enteroscopy in one arm and single balloon enteroscopy in the other arm in patients who satisfy inclusion criteria | Device | NOVEL MOTORIZED SPIRAL ENTEROSCOPY, SINGLE BALLOON ENTEROSCOPY |
Primary outcome
Rate of total enteroscopy (TER)
Time frame: 1 year
Number of cases in which total small bowel examination can be performed
6 secondary outcomes
Technical success of anterograde and retrograde approach
Time frame: 1 year
Procedural time (minutes)
Time frame: 1 year
Depth of maximum insertion (cm)
Time frame: 1 year
Diagnostic yield
Time frame: 1 year
Therapeutic success
Time frame: 1 year
Adverse events
Time frame: 1 year
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 27 Mar 2023.
- Background: PubMed 32663489Ramchandani M, Rughwani H, Inavolu P, Singh AP, Tevethia HV, Jagtap N, Sekaran A, Kanakagiri H, Darishetty S, Reddy DN. Diagnostic yield and therapeutic impact of novel motorized spiral enteroscopy in small-bowel disorders: a single-center, real-world experience from a tertiary care hospital (with video). Gastrointest Endosc. 2021 Mar;93(3):616-626. doi: 10.1016/j.gie.2020.07.001. Epub 2020 Jul 12.
- Background: PubMed 29539652Rondonotti E, Spada C, Adler S, May A, Despott EJ, Koulaouzidis A, Panter S, Domagk D, Fernandez-Urien I, Rahmi G, Riccioni ME, van Hooft JE, Hassan C, Pennazio M. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2018 Apr;50(4):423-446. doi: 10.1055/a-0576-0566. Epub 2018 Mar 14.
- Background: PubMed 19280530Buscaglia JM, Dunbar KB, Okolo PI 3rd, Judah J, Akerman PA, Cantero D, Draganov PV. The spiral enteroscopy training initiative: results of a prospective study evaluating the Discovery SB overtube device during small bowel enteroscopy (with video). Endoscopy. 2009 Mar;41(3):194-9. doi: 10.1055/s-0028-1119602. Epub 2009 Mar 11.
- Results publication: PubMed 28370422Yamamoto H, Ogata H, Matsumoto T, Ohmiya N, Ohtsuka K, Watanabe K, Yano T, Matsui T, Higuchi K, Nakamura T, Fujimoto K. Clinical Practice Guideline for Enteroscopy. Dig Endosc. 2017 Jul;29(5):519-546. doi: 10.1111/den.12883. Epub 2017 Jun 9.
- Clinical Practice Guideline for EnteroscopyLink provided by the sponsor.
- Diagnostic yield and therapeutic impact of novel motorized spiral enteroscopy in small-bowel disorders: a single-center, real-world experience from a tertiary care hospitalLink provided by the sponsor.
- Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical ReviewLink provided by the sponsor.
- The spiral enteroscopy training initiative: results of a prospective study evaluating the Discovery SB overtube device during small bowel enteroscopyLink provided by the sponsor.
- 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.
Dr Hardik Rughwani, MBBS, MD, DM principal investigator
AIG Hospitals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Motorized Spiral Enteroscopy in people with Small Bowel Disease, run by Asian Institute of Gastroenterology, India at 2 sites in 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 11 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 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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?
Rate of total enteroscopy (TER) (time frame: 1 year). 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 NCT05548140, which also lists 4 linked publications.
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 27 Mar 2023.