EndoscopyNCT05228353
Clinical Audit of GI Endoscopic Complications in a Tertiary Care Hospital
An observational study of Endoscopy and Complication, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Endoscopy of the upper gastrointestinal tract using fiberoptic endoscopes was introduced in the late 1950s and provided the first opportunity for direct visualization of the esophagus, stomach, and duodenum and colon in vivo. GI Endoscopy is usually considered a safe and effective procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endoscopy, Complication
- How many people
- 42,471 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2021to 31 Jan 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who undergo any diagnostic or therapeutic endoscopic procedure during the period and develop any complication will be enrolled in the study.
Who may be able to join
- All patients who undergo any diagnostic or therapeutic endoscopic procedure during the period and develop any complication including:
- Diagnostic and therapeutic upper gastrointestinal endoscopy,
- Diagnostic and therapeutic colonoscopy,
- Endoscopic retrograde cholangiopancreatography (ERCP),
- Endoscopic Ultrasound (EUS),
- Peroral Endoscopic Myotomy (POEM),
Show all 15Show fewer
- Enteroscopy (Antegrade, Retrograde or spiral)
- Endoscopic mucosal resection (EMR),
- Endoscopic Submucosal Resection (ESD),
- Submucosal Tunnel Endoscopic Resection (STER)
- Anti- Reflex Mucosal Ablation (ARMA)
- Anti- Reflex Mucosal Resection (ARMS)
- GERD-X
- Endoscopic Sleeve Gastrectomy (ESG)
- Intra-gastric Balloon insertion
Who cannot join
- Those who are not willing to give the consent.
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopy of the upper gastrointestinal tract using fiberoptic endoscopes was introduced in the late 1950s and provided the first opportunity for direct visualization of the esophagus, stomach, and duodenum and colon in vivo. GI Endoscopy is usually considered a safe and effective procedure. However complications do exist and procedure related costs are significant. There is a lack of prospective studies on complications of diagnostic and therapeutic endoscopic procedures.There is a lack of prospective studies on complications of diagnostic and therapeutic endoscopic procedures. Knowledge of potential endoscopic adverse events, their expected frequency, and the risk factors for their occurrence may help to minimize the incidence of adverse events. Review of adverse events as part of a continuing quality improvement process may serve to educate endoscopists, help to reduce the risk of future adverse events, and improve the overall quality of endoscopy.
Read the detailed description
- STUDY OBJECTIVES
1a. Primary objective - Clinical audit of complications in gastrointestinal endoscopy unit from a tertiary care centre.
1b. Secondary objective - NA
- STUDY POPULATION- Consecutive patients coming to the hospital for any gastrointestinal endoscopic procedure for 6 months duration and develops a complication.
- DESIGN AND DURATION OF THE STUDY- It will be an observational prospective audit of all consecutive patients coming to the hospital for any gastrointestinal endoscopic procedure for 6 months duration.
- METHODOLOGY
4a. SUBJECT RECRUITMENT - All patients who undergo any diagnostic or therapeutic endoscopic procedure during the period and develop any complication.
4b. RANDOMIZATION AND BLINDING- N/A
4c. STUDY METHODS- This observational study will be conducted after obtaining ethical clearance from institutional human ethical committee. All patients who undergo any endoscopic procedure during the period including upper gastrointestinal endoscopy, colonoscopy, endoscopic retrograde cholangiopancreatography (ERCP), Endoscopic Ultrasound (EUS), Peroral Endoscopic Myotomy (POEM), Enteroscopy, Endoscopic mucosal resection (EMR), Endoscopic Submucosal Resection (ESD), Submucosal Tunnel Endoscopic Resection (STER), Anti Reflux Mucosal resection (ARMS), Anti Reflux Mucosal ablation (ARMA), GERD-X, Endoscopic Sleeve Gastrectomy (ESG) and develops an complication will be enrolled in the study.
4d. STUDY PROCEDURE- For each patient who develops a complication , Following variables will be collected: Details of procedure, Indication of procedure, H/O Antiplatelets, anticoagulants, Any co-morbidity, Operator Characteristics, Time of procedure, Duration of procedure, Type of sedation, Time of detection of complication, Length of hospital stay/ICU stay, Mortality, Financial Cost, 30 days Follow-up, Re-admission rate, American Society of Anaesthesiologists (ASA) physical status classification, Relevant Images of the procedure, Relevant Videos of the procedure.
4e. METHODS OF ASSESSMENT- As per clinical protocol, each patient will be assessed by the primary investigator at 24 hours after their procedure to assess for possible symptoms and complications and to answer any questions. Further, for the purposes of this study, all patients will be contacted by telephone 30 days or more after their procedure. A standardized telephone interview and a review of the electronic medical record will be used to obtain follow-up data. Following complications will be recorded as per ASGE guidelines.
- Perforation
- Bleeding
- Infection
- Pancreatitis
- Cardio-pulmonary adverse event
- Pain/ discomfort
- Gas explosion
- Thromboembolism
- Instrumental penetration/ impaction
- Drug reaction
- Mortality 4f.STOPPING OR DISCONTINUATION CRITERIA- N/A
- SAMPLE SIZE CALCULATION- Since this is a clinical audit, all the patients coming for GI endoscopic procedures and developing complications will be recorded.
- STATISTICAL ANALYSIS- Statistical analysis including both univariate and multivariate analysis, when appropriate, on available data. Univariate analysis will be conducted using chi-square test, Fisher's exact test, and relative risks with their 95% confidence intervals. Multivariate analysis of the main predictors of complications will be performed using a forward stepwise logistic regression model with the SAS statistical system. All candidate independent variables, age included, will be analyzed in a dichotomous manner.
- ETHICAL JUSTIFICATION OF THE STUDY- GI Endoscopy is a safe and effective procedure. However complications do exist and procedure related costs are significant. There is a lack of prospective studies on complications of diagnostic and therapeutic endoscopic procedures. This study aims to quantify and identify risk factors associated with endoscopy procedure complications. Knowledge of potential endoscopic adverse events, their expected frequency, and the risk factors for their occurrence may help to minimize the incidence of adverse events. Review of adverse events as part of a continuing quality improvement process may serve to educate endoscopists, help to reduce the risk of future adverse events, and improve the overall quality of endoscopy.
- Conditions
- Endoscopy, Complication
- Keywords
- endoscopy, complication
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical audit of GI Endoscopic complications in a Tertiary Care Hospital
The study aims to do audit of all endoscopic procedures occurring over six months duration and record any complications occurring during that period. Information related to the complications will be recorded.
Measured: 6 months
Secondary outcomes (2)
Risk factors for endoscopy complications
The information will be recorded to find risk factors for procedures so that future complication rate can be reduced. Besides this will help us in comparing the mortality and morbidity rate as compared with what is described in literature.
Measured: 6 months
Morbidity associated with endoscopic complications
The study aims to review the morbidity associated with endoscopic complications during the study period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Jun 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for EndoscopyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42,471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inavolu Pradev, MBBS, MD, DM, Principal investigator, ConsultantHardik Rughwani, MBBS, MD, DM, Principal investigator, ConsultantMohan ramchandani, MBBS, MD, DM, Study director, ConsultantNageshwar D Reddy, MBBS, MD, DM, Study chair, ChiefAnudeep KV, MBBS, MD, DM, Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228353
- Sponsor's protocol ID
- AIG/IEC-BH&R 14/05.2021-03
- Status last verified
- Sep 2023
- First submitted
- 3 Jan 2022
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Publications
Wolfsen HC, Hemminger LL, Achem SR, Loeb DS, Stark ME, Bouras EP, DeVault KR. Complications of endoscopy of the upper gastrointestinal tract: a single-center experience. Mayo Clin Proc. 2004 Oct;79(10):1264-7. doi: 10.4065/79.10.1264.
PubMed 15473407Mahnke D, Chen YK, Antillon MR, Brown WR, Mattison R, Shah RJ. A prospective study of complications of endoscopic retrograde cholangiopancreatography and endoscopic ultrasound in an ambulatory endoscopy center. Clin Gastroenterol Hepatol. 2006 Jul;4(7):924-30. doi: 10.1016/j.cgh.2006.04.006. Epub 2006 Jun 22.
PubMed 16797251Loperfido S, Angelini G, Benedetti G, Chilovi F, Costan F, De Berardinis F, De Bernardin M, Ederle A, Fina P, Fratton A. Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study. Gastrointest Endosc. 1998 Jul;48(1):1-10. doi: 10.1016/s0016-5107(98)70121-x.
PubMed 9684657Levy I, Gralnek IM. Complications of diagnostic colonoscopy, upper endoscopy, and enteroscopy. Best Pract Res Clin Gastroenterol. 2016 Oct;30(5):705-718. doi: 10.1016/j.bpg.2016.09.005. Epub 2016 Sep 14.
PubMed 27931631Richter JM, Kelsey PB, Campbell EJ. Adverse Event and Complication Management in Gastrointestinal Endoscopy. Am J Gastroenterol. 2016 Mar;111(3):348-52. doi: 10.1038/ajg.2015.423. Epub 2016 Jan 12.
PubMed 26753887Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
PubMed 31863440Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
PubMed 20189503Katrevula A, Singla N, Rughwani H, Jagtap N, Katukuri GR, Godbole S, Teles de Campos S, Memon SF, Inavolu P, Singh AP, Mathur SS, Ashraf A, Patel R, Haja A, Asif S, Katamareddy T, Kalapala R, Ramchandani M, Lakhtakia S, Santosh D, Reddy N. Comprehensive audit of gastrointestinal endoscopy adverse events: Emphasizing quality indicators and economic impact with the AIG-AGREE modification. Endosc Int Open. 2024 Oct 28;12(10):E1242-E1250. doi: 10.1055/a-2435-5445. eCollection 2024 Oct.
PubMed 39474484
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Audit of GI Endoscopic Complications in a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT05228353
- Acronym / sponsor ID
- AIG/IEC-BH&R 14/05.2021-03
- Conditions
- Endoscopy, Complication
- Keywords
- endoscopy, complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42,471 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 8 Feb 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.
Endoscopy of the upper gastrointestinal tract using fiberoptic endoscopes was introduced in the late 1950s and provided the first opportunity for direct visualization of the esophagus, stomach, and duodenum and colon in vivo. GI Endoscopy is usually considered a safe and effective procedure. However complications do exist and procedure related costs are significant. There is a lack of prospective studies on complications of diagnostic and therapeutic endoscopic procedures.There is a lack of prospective studies on complications of diagnostic and therapeutic endoscopic procedures. Knowledge of potential endoscopic adverse events, their expected frequency, and the risk factors for their occurrence may help to minimize the incidence of adverse events. Review of adverse events as part of a continuing quality improvement process may serve to educate endoscopists, help to reduce the risk of future adverse events, and improve the overall quality of endoscopy.
Detailed description
- STUDY OBJECTIVES
1a. Primary objective - Clinical audit of complications in gastrointestinal endoscopy unit from a tertiary care centre.
1b. Secondary objective - NA
- STUDY POPULATION- Consecutive patients coming to the hospital for any gastrointestinal endoscopic procedure for 6 months duration and develops a complication.
- DESIGN AND DURATION OF THE STUDY- It will be an observational prospective audit of all consecutive patients coming to the hospital for any gastrointestinal endoscopic procedure for 6 months duration.
- METHODOLOGY
4a. SUBJECT RECRUITMENT - All patients who undergo any diagnostic or therapeutic endoscopic procedure during the period and develop any complication.
4b. RANDOMIZATION AND BLINDING- N/A
4c. STUDY METHODS- This observational study will be conducted after obtaining ethical clearance from institutional human ethical committee. All patients who undergo any endoscopic procedure during the period including upper gastrointestinal endoscopy, colonoscopy, endoscopic retrograde cholangiopancreatography (ERCP), Endoscopic Ultrasound (EUS), Peroral Endoscopic Myotomy (POEM), Enteroscopy, Endoscopic mucosal resection (EMR), Endoscopic Submucosal Resection (ESD), Submucosal Tunnel Endoscopic Resection (STER), Anti Reflux Mucosal resection (ARMS), Anti Reflux Mucosal ablation (ARMA), GERD-X, Endoscopic Sleeve Gastrectomy (ESG) and develops an complication will be enrolled in the study.
4d. STUDY PROCEDURE- For each patient who develops a complication , Following variables will be collected: Details of procedure, Indication of procedure, H/O Antiplatelets, anticoagulants, Any co-morbidity, Operator Characteristics, Time of procedure, Duration of procedure, Type of sedation, Time of detection of complication, Length of hospital stay/ICU stay, Mortality, Financial Cost, 30 days Follow-up, Re-admission rate, American Society of Anaesthesiologists (ASA) physical status classification, Relevant Images of the procedure, Relevant Videos of the procedure.
4e. METHODS OF ASSESSMENT- As per clinical protocol, each patient will be assessed by the primary investigator at 24 hours after their procedure to assess for possible symptoms and complications and to answer any questions. Further, for the purposes of this study, all patients will be contacted by telephone 30 days or more after their procedure. A standardized telephone interview and a review of the electronic medical record will be used to obtain follow-up data. Following complications will be recorded as per ASGE guidelines.
- Perforation
- Bleeding
- Infection
- Pancreatitis
- Cardio-pulmonary adverse event
- Pain/ discomfort
- Gas explosion
- Thromboembolism
- Instrumental penetration/ impaction
- Drug reaction
- Mortality 4f.STOPPING OR DISCONTINUATION CRITERIA- N/A
- SAMPLE SIZE CALCULATION- Since this is a clinical audit, all the patients coming for GI endoscopic procedures and developing complications will be recorded.
- STATISTICAL ANALYSIS- Statistical analysis including both univariate and multivariate analysis, when appropriate, on available data. Univariate analysis will be conducted using chi-square test, Fisher's exact test, and relative risks with their 95% confidence intervals. Multivariate analysis of the main predictors of complications will be performed using a forward stepwise logistic regression model with the SAS statistical system. All candidate independent variables, age included, will be analyzed in a dichotomous manner.
- ETHICAL JUSTIFICATION OF THE STUDY- GI Endoscopy is a safe and effective procedure. However complications do exist and procedure related costs are significant. There is a lack of prospective studies on complications of diagnostic and therapeutic endoscopic procedures. This study aims to quantify and identify risk factors associated with endoscopy procedure complications. Knowledge of potential endoscopic adverse events, their expected frequency, and the risk factors for their occurrence may help to minimize the incidence of adverse events. Review of adverse events as part of a continuing quality improvement process may serve to educate endoscopists, help to reduce the risk of future adverse events, and improve the overall quality of endoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who undergo any diagnostic or therapeutic endoscopic procedure during the period and develop any complication will be enrolled in the study.
Key inclusion criteria (15 listed)
- All patients who undergo any diagnostic or therapeutic endoscopic procedure during the period and develop any complication including:
Key exclusion criteria (1 listed)
- Those who are not willing to give the consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical audit of GI Endoscopic complications in a Tertiary Care Hospital
Time frame: 6 months
The study aims to do audit of all endoscopic procedures occurring over six months duration and record any complications occurring during that period. Information related to the complications will be recorded.
2 secondary outcomes
Risk factors for endoscopy complications
Time frame: 6 months
Morbidity associated with endoscopic complications
Time frame: 6 months
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 14 Sep 2023.
- Results publication: PubMed 15473407Wolfsen HC, Hemminger LL, Achem SR, Loeb DS, Stark ME, Bouras EP, DeVault KR. Complications of endoscopy of the upper gastrointestinal tract: a single-center experience. Mayo Clin Proc. 2004 Oct;79(10):1264-7. doi: 10.4065/79.10.1264.
- Results publication: PubMed 16797251Mahnke D, Chen YK, Antillon MR, Brown WR, Mattison R, Shah RJ. A prospective study of complications of endoscopic retrograde cholangiopancreatography and endoscopic ultrasound in an ambulatory endoscopy center. Clin Gastroenterol Hepatol. 2006 Jul;4(7):924-30. doi: 10.1016/j.cgh.2006.04.006. Epub 2006 Jun 22.
- Results publication: PubMed 9684657Loperfido S, Angelini G, Benedetti G, Chilovi F, Costan F, De Berardinis F, De Bernardin M, Ederle A, Fina P, Fratton A. Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study. Gastrointest Endosc. 1998 Jul;48(1):1-10. doi: 10.1016/s0016-5107(98)70121-x.
- Results publication: PubMed 27931631Levy I, Gralnek IM. Complications of diagnostic colonoscopy, upper endoscopy, and enteroscopy. Best Pract Res Clin Gastroenterol. 2016 Oct;30(5):705-718. doi: 10.1016/j.bpg.2016.09.005. Epub 2016 Sep 14.
- Results publication: PubMed 26753887Richter JM, Kelsey PB, Campbell EJ. Adverse Event and Complication Management in Gastrointestinal Endoscopy. Am J Gastroenterol. 2016 Mar;111(3):348-52. doi: 10.1038/ajg.2015.423. Epub 2016 Jan 12.
- Results publication: PubMed 31863440Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
- Results publication: PubMed 20189503Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
- Derived from this study: PubMed 39474484Katrevula A, Singla N, Rughwani H, Jagtap N, Katukuri GR, Godbole S, Teles de Campos S, Memon SF, Inavolu P, Singh AP, Mathur SS, Ashraf A, Patel R, Haja A, Asif S, Katamareddy T, Kalapala R, Ramchandani M, Lakhtakia S, Santosh D, Reddy N. Comprehensive audit of gastrointestinal endoscopy adverse events: Emphasizing quality indicators and economic impact with the AIG-AGREE modification. Endosc Int Open. 2024 Oct 28;12(10):E1242-E1250. doi: 10.1055/a-2435-5445. eCollection 2024 Oct.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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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.
Inavolu Pradev, MBBS, MD, DM principal investigator
Consultant
Hardik Rughwani, MBBS, MD, DM principal investigator
Consultant
Mohan ramchandani, MBBS, MD, DM study director
Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopy and Complication, run by Asian Institute of Gastroenterology, India at 1 site 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 15 inclusion and 1 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 14 Sep 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 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?
Clinical audit of GI Endoscopic complications in a Tertiary Care Hospital (time frame: 6 months). 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 NCT05228353, which also lists 8 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 14 Sep 2023.