AnemiaNCT02635217
Same Day Bidirectional Endoscopies - Does the Sequence of Procedures or Choice of Insufflator Matter?
A study testing Carbon dioxide insufflation, room air insufflation and EGD (Esophagogastroduodenoscopy) before Colonoscopy in people with Anemia and Colon Polyps, run by Queen's University at 1 site in Canada.
Trial summary
Upper endoscopies (Esophagogastroduodenoscopies-EGDs) as well as a lower endoscopies (Colonoscopies) are routinely performed by gastroenterologists to assess the lining of patients' upper and lower gastrointestinal tracts using a video endoscope (a long tube with a video camera on the end). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia, Colon Polyps
- What is being tested?
- Carbon dioxide insufflation, room air insufflation and EGD (Esophagogastroduodenoscopy) before Colonoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Dec 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- any patient with a clinical indication for receiving same day bi-directional endoscopies.
Who cannot join
- prior bowel or gastrointestinal surgery(s) (exception: appendectomy, cholecystectomy, hernia repair)
- known obstructive or cancerous lesions,
- active inflammatory bowel disease,
- hereditary polyposis syndromes,
- allergies to fentanyl and/or midazolam (SOC endoscopy sedatives),
- difficulties with communication or conditions affecting ability to provide informed consent,
- neurologic conditions that affect breathing (e.g. GBS, ALS or myasthenia gravis),
Trial locations and contacts
1 site in 1 country.
About this study
Upper endoscopies (Esophagogastroduodenoscopies-EGDs) as well as a lower endoscopies (Colonoscopies) are routinely performed by gastroenterologists to assess the lining of patients' upper and lower gastrointestinal tracts using a video endoscope (a long tube with a video camera on the end). An EGD is performed to examine the upper digestive tract to look for areas of inflammation, ulcerations, or other abnormalities in the swallowing tube, stomach, or duodenal lining. Similarly, a colonoscopy is performed to directly visualize the large bowel for polyps, inflammation, or other abnormalities in the lower bowel lining.
During these procedures, room air is routinely used to insufflate (expand/inflate the stomach and the colon) to allow for better viewing of the lining of the upper and lower gastrointestinal tracts; however, recently the use of carbon dioxide (CO2) (instead of air) has been shown to possibly have less post-procedure patient discomfort. Additionally, when both procedures are performed in the same day, it is currently unknown as to which sequence of procedures is better overall -whether to perform the EGD before colonoscopy or vice versa.
The overall aim of our research is to compare patients' comfort, total amount of sedation used, and overall satisfaction with the procedures between four randomly allocated groups, to see which method of insufflation and which procedural sequence is better when both procedures need to be performed in the same day. We hypothesize that in patients requiring same day endoscopies, performing an EGD prior to Colonoscopy with carbon dioxide (CO2) used as an insufflator is the best tolerated sequence associated with decreased sedation use and increased patient satisfaction/comfort.
Read the detailed description
Same day bi-directional endoscopies (EGD-esophagogastro-duodenoscopies and colonoscopies) are routinely performed in endoscopy units. Little however is known if the order of sequence of the two procedures (i.e. EGD (upper endoscopy) before colonoscopy (lower endoscopy) or vice-versa) is of any consequence. Those who favor performing EGDs prior to colonoscopies (EGD first approach) argue that the sedation necessary for EGD is then carried over to the colonoscopy and thus allows for a better tolerated colonoscopy. Additionally, abdominal bloating caused by insufflation of air during colonoscopy could lead to reduced tolerance of the subsequent EGD. Others however, argue that the gaseous distention of the small intestine caused by performing the EGD first leads to a more difficult and uncomfortable colonoscopy thereafter, likely due to a mechanical effect of air migrating to the proximal colon. Studies comparing procedural sequences in same day endoscopies have revealed conflicting results to date.
Some studies show that using the EGD first approach before allows for better procedural quality, decreased overall patient discomfort, less sedation, and a much higher chance of determining the diagnosis in the undifferentiated patient (e.g. occult GI bleeding). Other studies either show no difference in overall patient discomfort and satisfaction between both procedures, or even preference for colonoscopy before EGD. While some of these studies use moderate sedation, others use no sedation at all making generalization of these results difficult.
The use of carbon dioxide (CO2) for insufflation during upper and lower endoscopies has recently become popular over traditionally used room air, especially after studies revealed lesser post-procedure patient discomfort with the use of CO2. Whether its use affects the preferred sequence of procedures is still unknown.
Institutional variation across Canada regarding the sequence of procedures for same day bidirectional endoscopies is currently based on a combination of personal preferences and the few studies available. Given the absence of any formal guidelines in this area, we undertake the current study to test the hypothesis: In patients requiring same day bi-directional endoscopies, performing an EGD prior to Colonoscopy with carbon dioxide (CO2) used as an insufflator is the best tolerated sequence associated with decreased sedation use and increased patient satisfaction/comfort.
- Conditions
- Anemia, Colon Polyps
- Being tested
- Carbon dioxide insufflation, room air insufflation, EGD (Esophagogastroduodenoscopy) before Colonoscopy, Colonoscopy before EGD (Esophagogastroduodenoscopy)
- Keywords
- Colonoscopy, Esophagogastroduodenoscopy, Patient satisfaction, Bidirectional endoscopies
- Medical subject headings
- Anemia, Colonic Polyps, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon dioxide insufflationDevice
using an automated carbon dioxide insufflator the gas will be infused on demand during the endoscopies
room air insufflationDevice
using standard care room air will be infused on demand
EGD (Esophagogastroduodenoscopy) before ColonoscopyProcedure or surgery
the order of endoscopies will be randomized as well
Colonoscopy before EGD (Esophagogastroduodenoscopy)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A1 | Experimental | EGD performed before the Colonoscopy with Carbon Dioxide insufflation. Receives: Device: Carbon dioxide insufflation; Procedure: EGD (Esophagogastroduodenoscopy) before Colonoscopy |
| Group A2 | Experimental | EGD performed before the Colonoscopy with room air insufflation. Receives: Device: room air insufflation; Procedure: EGD (Esophagogastroduodenoscopy) before Colonoscopy |
| Group B1 | Experimental | Colonoscopy performed before the EGD with Carbon Dioxide insufflation. Receives: Device: Carbon dioxide insufflation; Procedure: Colonoscopy before EGD (Esophagogastroduodenoscopy) |
| Group B2 | Experimental | Colonoscopy performed before the EGD with room air insufflation. Receives: Device: room air insufflation; Procedure: Colonoscopy before EGD (Esophagogastroduodenoscopy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall patient satisfaction
Validated patient questionnaires administered to patients after both procedures are complete (on Day 0) followed by a recall interview via phone (on Day 7 after the procedures).
Measured: Day 0 (post procedure)
Secondary outcomes (3)
sedation use
Total sedation calculated as a total cumulative dose administered.
Measured: day 0 (day of procedure)
patient comfort
Patient comfort assessed by the nurses during the procedures using previously validated assessment scales.
Measured: day 0
Patient satisfaction
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lawrence Hookey, Queen's University
- Investigators
- Lawrence Hookey, MD, Study director, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635217
- Sponsor's protocol ID
- Bidirectional endoscopy study
- Status last verified
- May 2018
- First submitted
- 14 Dec 2015
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cho JH, Kim JH, Lee YC, Song SY, Lee SK. Comparison of procedural sequences in same-day bidirectional endoscopy without benzodiazepine and propofol sedation: starting at the bottom or the top. J Gastroenterol Hepatol. 2010 May;25(5):899-904. doi: 10.1111/j.1440-1746.2009.06157.x.
PubMed 20546443Zuckerman G, Benitez J. A prospective study of bidirectional endoscopy (colonoscopy and upper endoscopy) in the evaluation of patients with occult gastrointestinal bleeding. Am J Gastroenterol. 1992 Jan;87(1):62-6.
PubMed 1728127Carter D, Lahat A, Papageorgiou NP, Goldstein S, Eliakim R, Bardan E. Comparison of procedural sequence in same-day consecutive bidirectional endoscopy using moderate sedation: a prospective randomized study. J Clin Gastroenterol. 2014 Mar;48(3):236-40. doi: 10.1097/MCG.0b013e3182a87e5f.
PubMed 24100751Choi JS, Youn YH, Lee SK, Choi JY, Kim HM, Kim YJ, Han KJ, Cho HG, Song SY, Cho JH. Which should go first during same-day upper and lower gastrointestinal endoscopy? A randomized prospective study focusing on colonoscopy performance. Surg Endosc. 2013 Jun;27(6):2209-15. doi: 10.1007/s00464-012-2741-2. Epub 2013 Jan 26.
PubMed 23355152Hsieh YH, Lin HJ, Tseng KC. Which should go first during same-day bidirectional endosocopy with propofol sedation? J Gastroenterol Hepatol. 2011 Oct;26(10):1559-64. doi: 10.1111/j.1440-1746.2011.06786.x.
PubMed 21615790Kavitha K, Bharathi R, et. al Same Day Dual Endoscopy: Does the Sequence Matter? Gastrointestinal Endoscopy (abstract) 63.5 (2006) AB 145.
Sajid MS, Caswell J, Bhatti MI, Sains P, Baig MK, Miles WF. Carbon dioxide insufflation vs conventional air insufflation for colonoscopy: a systematic review and meta-analysis of published randomized controlled trials. Colorectal Dis. 2015 Feb;17(2):111-23. doi: 10.1111/codi.12837.
PubMed 25393051Kurien M, Din S, Dear KL, Elphick DA. Same day bidirectional endoscopy - does the procedural order matter? J Gastrointestin Liver Dis. 2012 Sep;21(3):328. No abstract available.
PubMed 23012681Rostom A, Ross ED, Dube C, Rutter MD, Lee T, Valori R, Bridges RJ, Pontifex D, Webbink V, Rees C, Brown C, Whetter DH, Kelsey SG, Hilsden RJ. Development and validation of a nurse-assessed patient comfort score for colonoscopy. Gastrointest Endosc. 2013 Feb;77(2):255-61. doi: 10.1016/j.gie.2012.10.003.
PubMed 23317691Munson GW, Van Norstrand MD, O'donnell JJ, Hammes NL, Francis DL. Intraprocedural evaluation of comfort for sedated outpatient upper endoscopy and colonoscopy: the La Crosse (WI) intra-endoscopy sedation comfort score. Gastroenterol Nurs. 2011 Jul-Aug;34(4):296-301. doi: 10.1097/SGA.0b013e3182248777.
PubMed 21814063Aronchick CA, Lipshutz WH, Wright SH, Dufrayne F, Bergman G. A novel tableted purgative for colonoscopic preparation: efficacy and safety comparisons with Colyte and Fleet Phospho-Soda. Gastrointest Endosc. 2000 Sep;52(3):346-52. doi: 10.1067/mge.2000.108480.
PubMed 10968848Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc. 2004 Apr;59(4):482-6. doi: 10.1016/s0016-5107(03)02875-x.
PubMed 15044882
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same Day Bidirectional Endoscopies - Does the Sequence of Procedures or Choice of Insufflator Matter?
- ClinicalTrials.gov ID
- NCT02635217
- Acronym / sponsor ID
- Bidirectional endoscopy study
- Conditions
- Anemia, Colon Polyps
- Keywords
- Colonoscopy, Esophagogastroduodenoscopy, Patient satisfaction, Bidirectional endoscopies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Dec 2015 (estimated)
- 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.
Upper endoscopies (Esophagogastroduodenoscopies-EGDs) as well as a lower endoscopies (Colonoscopies) are routinely performed by gastroenterologists to assess the lining of patients' upper and lower gastrointestinal tracts using a video endoscope (a long tube with a video camera on the end). An EGD is performed to examine the upper digestive tract to look for areas of inflammation, ulcerations, or other abnormalities in the swallowing tube, stomach, or duodenal lining. Similarly, a colonoscopy is performed to directly visualize the large bowel for polyps, inflammation, or other abnormalities in the lower bowel lining.
During these procedures, room air is routinely used to insufflate (expand/inflate the stomach and the colon) to allow for better viewing of the lining of the upper and lower gastrointestinal tracts; however, recently the use of carbon dioxide (CO2) (instead of air) has been shown to possibly have less post-procedure patient discomfort. Additionally, when both procedures are performed in the same day, it is currently unknown as to which sequence of procedures is better overall -whether to perform the EGD before colonoscopy or vice versa.
The overall aim of our research is to compare patients' comfort, total amount of sedation used, and overall satisfaction with the procedures between four randomly allocated groups, to see which method of insufflation and which procedural sequence is better when both procedures need to be performed in the same day. We hypothesize that in patients requiring same day endoscopies, performing an EGD prior to Colonoscopy with carbon dioxide (CO2) used as an insufflator is the best tolerated sequence associated with decreased sedation use and increased patient satisfaction/comfort.
Detailed description
Same day bi-directional endoscopies (EGD-esophagogastro-duodenoscopies and colonoscopies) are routinely performed in endoscopy units. Little however is known if the order of sequence of the two procedures (i.e. EGD (upper endoscopy) before colonoscopy (lower endoscopy) or vice-versa) is of any consequence. Those who favor performing EGDs prior to colonoscopies (EGD first approach) argue that the sedation necessary for EGD is then carried over to the colonoscopy and thus allows for a better tolerated colonoscopy. Additionally, abdominal bloating caused by insufflation of air during colonoscopy could lead to reduced tolerance of the subsequent EGD. Others however, argue that the gaseous distention of the small intestine caused by performing the EGD first leads to a more difficult and uncomfortable colonoscopy thereafter, likely due to a mechanical effect of air migrating to the proximal colon. Studies comparing procedural sequences in same day endoscopies have revealed conflicting results to date.
Some studies show that using the EGD first approach before allows for better procedural quality, decreased overall patient discomfort, less sedation, and a much higher chance of determining the diagnosis in the undifferentiated patient (e.g. occult GI bleeding). Other studies either show no difference in overall patient discomfort and satisfaction between both procedures, or even preference for colonoscopy before EGD. While some of these studies use moderate sedation, others use no sedation at all making generalization of these results difficult.
The use of carbon dioxide (CO2) for insufflation during upper and lower endoscopies has recently become popular over traditionally used room air, especially after studies revealed lesser post-procedure patient discomfort with the use of CO2. Whether its use affects the preferred sequence of procedures is still unknown.
Institutional variation across Canada regarding the sequence of procedures for same day bidirectional endoscopies is currently based on a combination of personal preferences and the few studies available. Given the absence of any formal guidelines in this area, we undertake the current study to test the hypothesis: In patients requiring same day bi-directional endoscopies, performing an EGD prior to Colonoscopy with carbon dioxide (CO2) used as an insufflator is the best tolerated sequence associated with decreased sedation use and increased patient satisfaction/comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A1 | Experimental | Device: Carbon dioxide insufflation, Procedure: EGD (Esophagogastroduodenoscopy) before ColonoscopyEGD performed before the Colonoscopy with Carbon Dioxide insufflation. |
| Group A2 | Experimental | Device: room air insufflation, Procedure: EGD (Esophagogastroduodenoscopy) before ColonoscopyEGD performed before the Colonoscopy with room air insufflation. |
| Group B1 | Experimental | Device: Carbon dioxide insufflation, Procedure: Colonoscopy before EGD (Esophagogastroduodenoscopy)Colonoscopy performed before the EGD with Carbon Dioxide insufflation. |
| Group B2 | Experimental | Device: room air insufflation, Procedure: Colonoscopy before EGD (Esophagogastroduodenoscopy)Colonoscopy performed before the EGD with room air insufflation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any patient with a clinical indication for receiving same day bi-directional endoscopies.
Key exclusion criteria (7 listed)
- prior bowel or gastrointestinal surgery(s) (exception: appendectomy, cholecystectomy, hernia repair)
- known obstructive or cancerous lesions,
- active inflammatory bowel disease,
- hereditary polyposis syndromes,
- allergies to fentanyl and/or midazolam (SOC endoscopy sedatives),
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 |
|---|---|---|
| Carbon dioxide insufflationusing an automated carbon dioxide insufflator the gas will be infused on demand during the endoscopies | Device | Group A1, Group B1 |
| room air insufflationusing standard care room air will be infused on demand | Device | Group A2, Group B2 |
| EGD (Esophagogastroduodenoscopy) before Colonoscopythe order of endoscopies will be randomized as well | Procedure or surgery | Group A1, Group A2 |
| Colonoscopy before EGD (Esophagogastroduodenoscopy) | Procedure or surgery | Group B1, Group B2 |
Primary outcome
Overall patient satisfaction
Time frame: Day 0 (post procedure)
Validated patient questionnaires administered to patients after both procedures are complete (on Day 0) followed by a recall interview via phone (on Day 7 after the procedures).
3 secondary outcomes
sedation use
Time frame: day 0 (day of procedure)
patient comfort
Time frame: day 0
Patient satisfaction
Time frame: Day 7
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 May 2018.
- Background: PubMed 20546443Cho JH, Kim JH, Lee YC, Song SY, Lee SK. Comparison of procedural sequences in same-day bidirectional endoscopy without benzodiazepine and propofol sedation: starting at the bottom or the top. J Gastroenterol Hepatol. 2010 May;25(5):899-904. doi: 10.1111/j.1440-1746.2009.06157.x.
- Background: PubMed 1728127Zuckerman G, Benitez J. A prospective study of bidirectional endoscopy (colonoscopy and upper endoscopy) in the evaluation of patients with occult gastrointestinal bleeding. Am J Gastroenterol. 1992 Jan;87(1):62-6.
- Background: PubMed 24100751Carter D, Lahat A, Papageorgiou NP, Goldstein S, Eliakim R, Bardan E. Comparison of procedural sequence in same-day consecutive bidirectional endoscopy using moderate sedation: a prospective randomized study. J Clin Gastroenterol. 2014 Mar;48(3):236-40. doi: 10.1097/MCG.0b013e3182a87e5f.
- Background: PubMed 23355152Choi JS, Youn YH, Lee SK, Choi JY, Kim HM, Kim YJ, Han KJ, Cho HG, Song SY, Cho JH. Which should go first during same-day upper and lower gastrointestinal endoscopy? A randomized prospective study focusing on colonoscopy performance. Surg Endosc. 2013 Jun;27(6):2209-15. doi: 10.1007/s00464-012-2741-2. Epub 2013 Jan 26.
- Background: PubMed 21615790Hsieh YH, Lin HJ, Tseng KC. Which should go first during same-day bidirectional endosocopy with propofol sedation? J Gastroenterol Hepatol. 2011 Oct;26(10):1559-64. doi: 10.1111/j.1440-1746.2011.06786.x.
- BackgroundKavitha K, Bharathi R, et. al Same Day Dual Endoscopy: Does the Sequence Matter? Gastrointestinal Endoscopy (abstract) 63.5 (2006) AB 145.
- Background: PubMed 25393051Sajid MS, Caswell J, Bhatti MI, Sains P, Baig MK, Miles WF. Carbon dioxide insufflation vs conventional air insufflation for colonoscopy: a systematic review and meta-analysis of published randomized controlled trials. Colorectal Dis. 2015 Feb;17(2):111-23. doi: 10.1111/codi.12837.
- Background: PubMed 23012681Kurien M, Din S, Dear KL, Elphick DA. Same day bidirectional endoscopy - does the procedural order matter? J Gastrointestin Liver Dis. 2012 Sep;21(3):328. No abstract available.
- Background: PubMed 23317691Rostom A, Ross ED, Dube C, Rutter MD, Lee T, Valori R, Bridges RJ, Pontifex D, Webbink V, Rees C, Brown C, Whetter DH, Kelsey SG, Hilsden RJ. Development and validation of a nurse-assessed patient comfort score for colonoscopy. Gastrointest Endosc. 2013 Feb;77(2):255-61. doi: 10.1016/j.gie.2012.10.003.
- Background: PubMed 21814063Munson GW, Van Norstrand MD, O'donnell JJ, Hammes NL, Francis DL. Intraprocedural evaluation of comfort for sedated outpatient upper endoscopy and colonoscopy: the La Crosse (WI) intra-endoscopy sedation comfort score. Gastroenterol Nurs. 2011 Jul-Aug;34(4):296-301. doi: 10.1097/SGA.0b013e3182248777.
- Background: PubMed 10968848Aronchick CA, Lipshutz WH, Wright SH, Dufrayne F, Bergman G. A novel tableted purgative for colonoscopic preparation: efficacy and safety comparisons with Colyte and Fleet Phospho-Soda. Gastrointest Endosc. 2000 Sep;52(3):346-52. doi: 10.1067/mge.2000.108480.
- Background: PubMed 15044882Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc. 2004 Apr;59(4):482-6. doi: 10.1016/s0016-5107(03)02875-x.
- 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.
Lawrence Hookey, MD study director
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon dioxide insufflation, room air insufflation and EGD (Esophagogastroduodenoscopy) before Colonoscopy in people with Anemia and Colon Polyps, run by Queen's University at 1 site in Canada.
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 1 inclusion and 7 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 May 2018. 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 Canada. 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?
Overall patient satisfaction (time frame: Day 0 (post procedure)). 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 NCT02635217, which also lists 12 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 9 May 2018.