DyspepsiaNCT03420729
Acceptability and Tolerability of Magnetic Assisted Capsule Endoscopy Compared to Gastroscopy
A study testing gastroscopy and magnetic assisted capsule endoscopy in people with Dyspepsia, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Dyspepsia is a common presenting complaint that doctors have to manage and this is true both in the primary and secondary care setting. OGD is a useful test for investigating a variety of suspected upper GI disorders including dyspepsia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- gastroscopy and magnetic assisted capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Mar 2017to 1 Sep 2020
- 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
- Patients aged 18 years and over and up to but not exceeding 80 years
- Patients presenting symptoms of dyspepsia whom require gastroscopy as per national guidelines
Who cannot join
- Patients under the age of 18 years
- Patients over the age of 80 years
- Active vomiting
- Patients with a permanent pacemaker, implantable cardioverter-defibrillator or REVEAL device
- Patients with any electronic/magnetic/mechanically controlled devices e.g. sacral nerve stimulators, bladder stimulators
- Patients with dysphagia, odynophagia or known swallowing disorder
Show all 26Show fewer
- Patients with known Zenker's diverticulum
- Patients with suspected bowel obstruction or bowel perforation
- Patients with prior bowel obstruction
- Patients with gastroparesis or known gastric outlet obstruction
- Patients with known Crohn's disease
- Patients who are taking daily non-steroidal anti-inflammatory drugs (excluding prophylactic doses of aspirin) for more than six months
- Patients who have received abdominopelvic radiotherapy treatment
- Patients with a history of GI tract surgery (Billroth I, Billroth II, Oesophagectomy, gastrectomy or bariatric procedure)
- Patients that are pregnant or lactating
- Patients with altered mental status that would limit their ability to swallow
- Patients with allergy to conscious sedation or metoclopramide
- Patients unwilling to swallow the capsule
- Patients with known dementia affecting ability to consent
- Patients who are unable to understand or speak English
- Patients unable to provide written informed consent
- Patients with head and neck cancers
- Patients who have had nasal surgery, eg. rhinnoplasty
- Patients allergic to lidocaine, pheylephirine or midazolam
- Patient with bleeding diathesis, on warfarin or have chronic liver disease
- Patients reluctant to have gastroscopy by both oral or transnasal route
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
Dyspepsia is a common presenting complaint that doctors have to manage and this is true both in the primary and secondary care setting. OGD is a useful test for investigating a variety of suspected upper GI disorders including dyspepsia. However, it is uncomfortable for patients and incurs the risk of intubation and sedation. Capsule endoscopy (CE) is the investigation of choice for diseases of the small bowel. It is safe, non-invasive and well tolerated, the main risk being capsule retention occurring in up to 1-2% of procedures.
The investigators wish to undertake a prospective study comparing acceptability and tolerability of MACE and OGD in the investigation of dyspepsia. Patients presenting to general practice or the outpatients department with symptoms of dyspepsia who are referred for investigation are invited to take part in the study. Patients will undergo MACE prior to OGD performed by an endoscopist blinded to the MACE findings. . A comparison of tolerance and acceptance of both procedures will be measured by means of using structured and validated, qualitative questionnaires. The aim is to assess for whether there is a significant difference between the perception and experience of both modalities.
Read the detailed description
This is a prospective, single blinded, comparative trial of patient acceptability and tolerability of MACE and both transoral and transnasal gastroscopy in the investigation of dyspepsia.
The study will be conducted within Sheffield Teaching Hospitals. Recruitment will take place at the Sloan Medical Centre, the Royal Hallamshire Hospital or the Northern General Hospital during the consultation when patients present with dyspepsia requiring gastroscopy for investigation as per national guidelines. MACE will take place at the Sloan Medical Centre. Equipment for collecting demographics (height, weight etc) will be available. All the capsule equipment is stored and re-charged in this designated room. The case report files and computer data will be stored in this room that is secured by a locked door.
Gastroscopy will take place in the Endoscopy Departments, which are specially designed units for a variety of endoscopic tests, at the Royal Hallamshire Hospital and Northern General Hospital.
Patients are assessed in the Sloan Medical Centre or the Royal Hallamshire Hospital/Northern General Hospital outpatients department for their primary presenting complaints of dyspepsia. The study will be discussed with patients in those who satisfy the enrolment criteria and they will be provided by with the written study literature. If in agreement to enter the study, informed written consent will be obtained from the patient.
Prior to any investigation, the pre-MACE section of the questionnaire will be completed by the patient with the assistance of study team members. MACE will be performed at the Sloan Medical Centre; this will be in a dedicated room setup to accommodate the MACE procedure.The post-MACE section of the questionnaire will then be completed by the patient with the assistance of study team members. MACE will be preceded by obtaining measurements of height, weight and waist/hip circumference. The patient will then be given 500 to 1000mls of water with 6 drops of simethicone added to drink. This is to enable adequate distension of the stomach. Our previous study has shown excellent tolerance of this volume of water distension by patient.
The patient then swallows the capsule in the presence of the PI. MACE of the oesophagus and stomach will be carried out by the PI. Once the PI is satisfied that an adequate examination has been completed the capsule will be allowed to pass into and through the small bowel. Visibility of major locations of the stomach will be documented. Any pathology noted will be recorded according to the standard fashion described for gastroscopy reporting. A note of the procedure duration will be recorded. The patient will be given the option to complete their small bowel capsule endoscopy in the standard way and this will be reported in the usual fashion.
Patients referred for gastroscopy as part of the normal pathway for investigation of dyspepsia, will attend a designated list for their gastroscopy within 1 week and this will be performed by a JAG accredited endoscopist who has experience in endoscopic therapy. TOG will be performed using a standard 11mm Olympus or Pentax gastroscope and TNG will be performed using an ultra-thin 5.9mm Olympus or Fujinon gastroscope. The endoscopist performing the gastroscopy will be a member of the study team. The participant will be asked to complete the pre-gastroscopy section of the participant questionnaire before, and the post-gastroscopy section after the procedure.
Patients will have 80mg simethicone mixed in 100mls of water as an anti-foaming agent prior to the gastroscopy. Patients undergoing TNG will have their nasal passages prepared with a fine mist of 5% lidocaine and 0.5% phenylephrine (co-phenylephrine nasal spray) which are a local anaesthetic and nasal decongestant. Phenylephrine is a topical vasoconstrictor used as a nasal decongestant to reduce the risk of peri-procedure epistaxis. Five minutes following this, a 6mm diameter soft-sillicone catheter lubricated with 2% aqueous lidocaine gel is inserted into either or each nasal passage approximately 5-8cm passages to ensure the passage is wide enough to comfortably accommodate a nasal endoscopy. If neither passages accommodate the silicone catheter, the procedure will be converted to a transoral route. Patients undergoing TOG will have 10 sprays of 10% topical lidocaine administered to the oropharynx. Procedures will be performed in the left lateral decubitus position.
Gastroscopy will be performed in the standard fashion and reported to the PI to compose a written record for study purposes. This reporting system (InfoFlex) requires details to be entered regarding indication for examination, patient comfort, sedation and pathology. Pathology will be documented in a standardised way (for further details see section on Scientific Justification). An entry of the duration of procedure will be included. This denotes the end of the participants' involvement in the study. The patient will be managed thereafter according to the responsible clinician at the Sloan Medical Centre or Sheffield Teaching Hospitals NHS Trust.
The primary outcome will be evaluated using the questionnaires to compare acceptability and tolerance of both procedures.
- Conditions
- Dyspepsia
- Being tested
- gastroscopy, magnetic assisted capsule endoscopy
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastroscopyProcedure or surgery
a thin, flexible tube called an end oscope is used to look inside the oesophagus (gullet), stomach and first part of the small intestine (duodenum)
magnetic assisted capsule endoscopyDevice
The patient will be given 500 to 1000mls of water with 6 drops of simethicone added to drink. This is to enable adequate distension of the stomach. The patient then swallows the capsule in the presence of the PI. MACE of the oesophagus and stomach will be carried out by the PI. Once the PI is satisfied that an adequate examination has been completed the capsule will be allowed to pass into and through the small bowel.
| Study group | Role | What they receive |
|---|---|---|
| magnetic assisted capsule endoscopy | Experimental | All participants will undergo magnetic assisted capsule endoscopy at the sloan medical centre Receives: Procedure: gastroscopy; Device: magnetic assisted capsule endoscopy |
| gastroscopy | Active comparator | All participants will undergo gastroscopy as standard of care at sheffield teaching hospitals Receives: Procedure: gastroscopy; Device: magnetic assisted capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopy Concerns Score
Differences in the Endoscopy Concerns Score (ECS) when patients have magnetic assisted capsule endoscopy (MACE) and when they have conventional gastroscopy
Measured: procedure
Secondary outcomes (1)
Clinician rating of visualization of upper GI Tract
Differences in visualization of the upper GI tract
Measured: procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start7 Mar 2017
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark McAlindon, Principal investigator, Sheffield Teaching Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420729
- Sponsor's protocol ID
- STH19595
- Status last verified
- Apr 2024
- First submitted
- 29 Jan 2018
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Tolerability of Magnetic Assisted Capsule Endoscopy Compared to Gastroscopy
- ClinicalTrials.gov ID
- NCT03420729
- Acronym / sponsor ID
- STH19595
- Conditions
- Dyspepsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 5 Feb 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.
Dyspepsia is a common presenting complaint that doctors have to manage and this is true both in the primary and secondary care setting. OGD is a useful test for investigating a variety of suspected upper GI disorders including dyspepsia. However, it is uncomfortable for patients and incurs the risk of intubation and sedation. Capsule endoscopy (CE) is the investigation of choice for diseases of the small bowel. It is safe, non-invasive and well tolerated, the main risk being capsule retention occurring in up to 1-2% of procedures.
The investigators wish to undertake a prospective study comparing acceptability and tolerability of MACE and OGD in the investigation of dyspepsia. Patients presenting to general practice or the outpatients department with symptoms of dyspepsia who are referred for investigation are invited to take part in the study. Patients will undergo MACE prior to OGD performed by an endoscopist blinded to the MACE findings. . A comparison of tolerance and acceptance of both procedures will be measured by means of using structured and validated, qualitative questionnaires. The aim is to assess for whether there is a significant difference between the perception and experience of both modalities.
Detailed description
This is a prospective, single blinded, comparative trial of patient acceptability and tolerability of MACE and both transoral and transnasal gastroscopy in the investigation of dyspepsia.
The study will be conducted within Sheffield Teaching Hospitals. Recruitment will take place at the Sloan Medical Centre, the Royal Hallamshire Hospital or the Northern General Hospital during the consultation when patients present with dyspepsia requiring gastroscopy for investigation as per national guidelines. MACE will take place at the Sloan Medical Centre. Equipment for collecting demographics (height, weight etc) will be available. All the capsule equipment is stored and re-charged in this designated room. The case report files and computer data will be stored in this room that is secured by a locked door.
Gastroscopy will take place in the Endoscopy Departments, which are specially designed units for a variety of endoscopic tests, at the Royal Hallamshire Hospital and Northern General Hospital.
Patients are assessed in the Sloan Medical Centre or the Royal Hallamshire Hospital/Northern General Hospital outpatients department for their primary presenting complaints of dyspepsia. The study will be discussed with patients in those who satisfy the enrolment criteria and they will be provided by with the written study literature. If in agreement to enter the study, informed written consent will be obtained from the patient.
Prior to any investigation, the pre-MACE section of the questionnaire will be completed by the patient with the assistance of study team members. MACE will be performed at the Sloan Medical Centre; this will be in a dedicated room setup to accommodate the MACE procedure.The post-MACE section of the questionnaire will then be completed by the patient with the assistance of study team members. MACE will be preceded by obtaining measurements of height, weight and waist/hip circumference. The patient will then be given 500 to 1000mls of water with 6 drops of simethicone added to drink. This is to enable adequate distension of the stomach. Our previous study has shown excellent tolerance of this volume of water distension by patient.
The patient then swallows the capsule in the presence of the PI. MACE of the oesophagus and stomach will be carried out by the PI. Once the PI is satisfied that an adequate examination has been completed the capsule will be allowed to pass into and through the small bowel. Visibility of major locations of the stomach will be documented. Any pathology noted will be recorded according to the standard fashion described for gastroscopy reporting. A note of the procedure duration will be recorded. The patient will be given the option to complete their small bowel capsule endoscopy in the standard way and this will be reported in the usual fashion.
Patients referred for gastroscopy as part of the normal pathway for investigation of dyspepsia, will attend a designated list for their gastroscopy within 1 week and this will be performed by a JAG accredited endoscopist who has experience in endoscopic therapy. TOG will be performed using a standard 11mm Olympus or Pentax gastroscope and TNG will be performed using an ultra-thin 5.9mm Olympus or Fujinon gastroscope. The endoscopist performing the gastroscopy will be a member of the study team. The participant will be asked to complete the pre-gastroscopy section of the participant questionnaire before, and the post-gastroscopy section after the procedure.
Patients will have 80mg simethicone mixed in 100mls of water as an anti-foaming agent prior to the gastroscopy. Patients undergoing TNG will have their nasal passages prepared with a fine mist of 5% lidocaine and 0.5% phenylephrine (co-phenylephrine nasal spray) which are a local anaesthetic and nasal decongestant. Phenylephrine is a topical vasoconstrictor used as a nasal decongestant to reduce the risk of peri-procedure epistaxis. Five minutes following this, a 6mm diameter soft-sillicone catheter lubricated with 2% aqueous lidocaine gel is inserted into either or each nasal passage approximately 5-8cm passages to ensure the passage is wide enough to comfortably accommodate a nasal endoscopy. If neither passages accommodate the silicone catheter, the procedure will be converted to a transoral route. Patients undergoing TOG will have 10 sprays of 10% topical lidocaine administered to the oropharynx. Procedures will be performed in the left lateral decubitus position.
Gastroscopy will be performed in the standard fashion and reported to the PI to compose a written record for study purposes. This reporting system (InfoFlex) requires details to be entered regarding indication for examination, patient comfort, sedation and pathology. Pathology will be documented in a standardised way (for further details see section on Scientific Justification). An entry of the duration of procedure will be included. This denotes the end of the participants' involvement in the study. The patient will be managed thereafter according to the responsible clinician at the Sloan Medical Centre or Sheffield Teaching Hospitals NHS Trust.
The primary outcome will be evaluated using the questionnaires to compare acceptability and tolerance of both procedures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| magnetic assisted capsule endoscopy | Experimental | Procedure: gastroscopy, Device: magnetic assisted capsule endoscopyAll participants will undergo magnetic assisted capsule endoscopy at the sloan medical centre |
| gastroscopy | Active comparator | Procedure: gastroscopy, Device: magnetic assisted capsule endoscopyAll participants will undergo gastroscopy as standard of care at sheffield teaching hospitals |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 years and over and up to but not exceeding 80 years
- Patients presenting symptoms of dyspepsia whom require gastroscopy as per national guidelines
Key exclusion criteria (26 listed)
- Patients under the age of 18 years
- Patients over the age of 80 years
- Active vomiting
- Patients with a permanent pacemaker, implantable cardioverter-defibrillator or REVEAL device
- Patients with any electronic/magnetic/mechanically controlled devices e.g. sacral nerve stimulators, bladder stimulators
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 |
|---|---|---|
| gastroscopya thin, flexible tube called an end oscope is used to look inside the oesophagus (gullet), stomach and first part of the small intestine (duodenum) | Procedure or surgery | gastroscopy, magnetic assisted capsule endoscopy |
| magnetic assisted capsule endoscopyThe patient will be given 500 to 1000mls of water with 6 drops of simethicone added to drink. This is to enable adequate distension of the stomach. The patient then swallows the capsule in the presence of the PI. MACE of the oesophagus and stomach will be carried out by the PI. Once the PI is satisfied that an adequate examination has been completed the capsule will be allowed to pass into and through the small bowel. | Device | gastroscopy, magnetic assisted capsule endoscopy |
Primary outcome
Endoscopy Concerns Score
Time frame: procedure
Differences in the Endoscopy Concerns Score (ECS) when patients have magnetic assisted capsule endoscopy (MACE) and when they have conventional gastroscopy
1 secondary outcome
Clinician rating of visualization of upper GI Tract
Time frame: procedure
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 25 Apr 2024.
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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.
Mark McAlindon principal investigator
Sheffield Teaching Hospitals NHS FT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gastroscopy and magnetic assisted capsule endoscopy in people with Dyspepsia, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 26 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 25 Apr 2024. 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 United Kingdom. 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?
Endoscopy Concerns Score (time frame: procedure). 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 25 Apr 2024.