Aspiration PneumoniasNCT06717321
Percutaneous Endoscopic Gastrostomy Versus Percutaneous Endoscopic Gastrostomy With Jejunal Extension
A study testing (Arm 1): PEG and (Arm 2): PEG-J in people with Aspiration Pneumonias and Tube Feeding, run by Jerry Dang at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if placing a feeding tube with a small bowel extension (called Percutaneous Endoscopic Gastrostomy With Jejunal Extension [PEG-J]) is better at preventing pneumonia than a standard feeding tube (called Percutaneous Endoscopic Gastrostomy [PEG]) in people who need long-term… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aspiration Pneumonias, Tube Feeding, Enteral Feeds
- What is being tested?
- (Arm 1): PEG and (Arm 2): PEG-J
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2025to 10 Jun 2025
- 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
- Age 18 years or older
- Requires feeding access as determined by treating provider
Who cannot join
- Concurrent pneumonia at time of enrollment
- Concurrent COVID-19 diagnosis
- Prior feeding access (transabdominal feeding access)
- Prior upper gastrointestinal surgery (previous gastric resection surgery)
- Gastroparesis
- Obstruction or pseudo-obstruction
Show all 10Show fewer
- Pregnancy
- Contraindication to undergo upper endoscopy
- Prisoners
- Primary language is not English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Endoscopic Gastrostomy Versus Percutaneous Endoscopic Gastrostomy With Jejunal Extension: A Randomized Clinical Trial
The goal of this clinical trial is to learn if placing a feeding tube with a small bowel extension (called Percutaneous Endoscopic Gastrostomy With Jejunal Extension [PEG-J]) is better at preventing pneumonia than a standard feeding tube (called Percutaneous Endoscopic Gastrostomy [PEG]) in people who need long-term tube feeding. Researchers want to know if people who receive a PEG-J have fewer cases of pneumonia in the first 30 days compared to those who receive a standard PEG, and whether PEG-J tubes require more follow-up procedures to fix tube problems.
Researchers will compare two different types of feeding tubes: a standard feeding tube that goes into the stomach (PEG) versus a feeding tube that extends past the stomach into the small intestine (PEG-J). This will help determine which type of feeding tube is safer and works better for patients.
Read more
Participants will be randomly assigned to receive either a PEG or PEG-J feeding tube through a minimally invasive procedure. They will start receiving nutrition through the tube 24 hours after placement and be monitored for 30 days to check for problems like pneumonia or tube malfunction, while receiving regular medical care from their treating doctors.
The study is open to people who are 18 years or older and need a new feeding tube for long-term nutrition. People cannot take part if they have pneumonia, COVID-19, an existing feeding tube, previous stomach surgery, gastroparesis (a condition affecting stomach movement), digestive system blockage, are pregnant, or are in prison. All participants must understand English.
Participation is voluntary, and participants can leave the study at any time. The study team will carefully monitor all participants for any problems throughout the 30-day period
Read the detailed description
This randomized clinical trial investigates the comparative efficacy of percutaneous endoscopic gastrostomy (PEG) versus percutaneous endoscopic gastrostomy with jejunal extension (PEGJ) for long-term enteral access. The study addresses a critical knowledge gap in the literature regarding the optimal approach for enteral feeding in patients at risk for aspiration.
Current evidence suggests that aspiration pneumonia occurs in up to 30% of patients following PEG placement, with some studies demonstrating aspiration in up to 38% of patients immediately after enteral feeding administration. This high rate is hypothesized to result from gastric reflux. While PEGJ has been proposed as a potential solution by advancing feeds beyond the pylorus, existing evidence consists primarily of small case series and retrospective studies, with reported aspiration pneumonia rates of approximately 10%. However, the methodological limitations of these studies and contradicting findings create uncertainty about the optimal approach.
A recent meta-analysis of enteral feeding in critically ill patients suggested potential benefits of post-pyloric feeding, but included moderate to low quality evidence and did not directly compare PEG versus PEGJ. Furthermore, some researchers argue that aspiration events may result from oropharyngeal dysphagia rather than gastric reflux, potentially limiting the benefit of jejunal extension.
The study employs a prospective, randomized design with 1:1 allocation using distance randomization via RedCap to ensure allocation concealment. Sample size calculation was based on detecting a 20% difference between groups in aspiration pneumonia rates, with power analysis accounting for a statistical power of 0.8 using chi-square test methodology.
The technical aspects of tube placement follow standardized protocols. For PEG placement, a 20-French pull-type tube is positioned using safe track technique with transillumination and 1:1 finger indentation, placing the tube midway between the greater and lesser curves of the stomach. The PEGJ procedure begins similarly but utilizes a 24-French pull-type PEG followed by advancement of a 12-French jejunal extension tube, which is secured to the small bowel wall with endoclips as indicated.
Both groups will receive continuous feeding rather than bolus feeding to standardize the feeding methodology. The study design accounts for potential confounding factors by excluding patients with conditions that might independently affect aspiration risk or tube function, such as gastroparesis or prior upper gastrointestinal surgery.
The research addresses both clinical efficacy and practical considerations, as PEGJ tubes have reported malfunction rates of up to 50%, potentially requiring additional interventions. This prospective investigation will provide high-quality evidence to guide clinical decision-making, balancing the potential benefits of aspiration reduction against the risks of tube dysfunction and need for reintervention.
Statistical analysis will be conducted by an internal biostatistician using appropriate methodologies for both continuous and categorical variables, with adjustments for non-normal distributions when necessary. The study's 30-day follow-up period was selected based on typical timeframes for post-procedure complications and tube-related adverse events.
- Conditions
- Aspiration Pneumonias, Tube Feeding, Enteral Feeds
- Being tested
- (Arm 1): PEG, (Arm 2): PEG-J
- Keywords
- tube feeds, aspiration pneumonia, peg, peg-J, enteral feeding
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Arm 1): PEGProcedure or surgery
A 20-French pull type percutaneous endoscopic feeding tube placed into the stomach using endoscopic guidance
(Arm 2): PEG-JProcedure or surgery
24-French pull type percutaneous endoscopic feeding tube placed into the stomach with a 12-French jejunal extension tube advanced through the PEG and positioned post-pyloric in the small bowel using endoscopic guidance
| Study group | Role | What they receive |
|---|---|---|
| PEG arm: Patients receiving the 20-French pull-type PEG tube | Active comparator | PEG Arm:
Participants receive a 20-French pull-type percutaneous endoscopic gastrostomy tube placed into the stomach using standard safe track technique with transillumination and 1:1 finger indentation. The tube is positioned midway between the greater and lesser curves of the stomach. Continuous tube feeds begin 24 hours after placement. Follow-up period is 30 days. Receives: Procedure: (Arm 1): PEG |
| PEG-J arm: Patients receiving the 24-French pull-type PEG with 12-French jejunal extension tube | Active comparator | Participants receive a 24-French pull-type percutaneous endoscopic gastrostomy tube with a 12-French jejunal extension. After standard PEG placement, the jejunal extension tube is advanced past the pylorus and secured to the small bowel wall with endoclips as indicated. Continuous tube feeds begin 24 hours after placement. Follow-up period is 30 days. Receives: Procedure: (Arm 2): PEG-J |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Developed Post-Procedure Pneumonia
Diagnosis of pneumonia will be determined based on clinical judgment of the treating provider and must be explicitly documented as "pneumonia" in the medical record.
Measured: From day of procedure (day 0) through 30 days post-procedure
Secondary outcomes (3)
Number of Participants Requiring Additional Procedures Due to Tube Malfunction
A tube malfunction is defined as any issue requiring an additional procedure to maintain tube function.
Measured: From day of procedure (day 0) through 30 days post-procedure
Number of Participants with Post-Operative Complications
Any documented post-operative complication will be counted, including but not limited to bleeding, infection, and injury to organs or structures
Measured: From day of procedure (day 0) through 30 days post-procedure
Total Procedure Time in Minutes from Start to Completion of Feeding Tube Placement
Measurement of total operative time from the start of the endoscopic procedure until completion of feeding tube placement and final endoscopic verification of proper positioning. Time will be measured in minutes.
Measured: Day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start27 Feb 2025
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Why it stopped: Difficulty Enrolling
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Aspiration PneumoniasStudies 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
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jerry Dang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jerry Dang, The Cleveland Clinic
- Investigators
- Jerry Dang, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717321
- Sponsor's protocol ID
- 23-170
- Status last verified
- Aug 2025
- First submitted
- 3 Dec 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Based on the protocol's data collection and privacy sections, individual participant data (IPD) that underlie the results reported in published articles will not be shared. The IRB-approved protocol specifies that data access is restricted to the research team and regulatory instances at Cleveland Clinic. As per protocol's privacy and confidentiality section, data will be safeguarded in REDCap with access limited to authorized study personnel, and data retention is specified for 5 years after study completion. These limitations on data sharing are in place to maintain participant confidentiality and comply with the privacy protections promised during the informed consent process.
Publications
Fox KA, Mularski RA, Sarfati MR, Brooks ME, Warneke JA, Hunter GC, Rappaport WD. Aspiration pneumonia following surgically placed feeding tubes. Am J Surg. 1995 Dec;170(6):564-6; discussion 566-7. doi: 10.1016/s0002-9610(99)80016-6.
PubMed 7492001Chang WK, Huang HH, Lin HH, Tsai CL. Evaluation of Oropharyngeal Dysphagia in Patients Who Underwent Percutaneous Endoscopic Gastrostomy: Stratification Risk of Pneumonia. JPEN J Parenter Enteral Nutr. 2020 Feb;44(2):239-245. doi: 10.1002/jpen.1592. Epub 2019 Apr 14.
PubMed 30983013Gauderer MW, Ponsky JL, Izant RJ Jr. Gastrostomy without laparotomy: a percutaneous endoscopic technique. J Pediatr Surg. 1980 Dec;15(6):872-5. doi: 10.1016/s0022-3468(80)80296-x.
PubMed 6780678Minard G. The history of surgically placed feeding tubes. Nutr Clin Pract. 2006 Dec;21(6):626-33. doi: 10.1177/0115426506021006626.
PubMed 17119170Seres DS, Valcarcel M, Guillaume A. Advantages of enteral nutrition over parenteral nutrition. Ther Adv Gastroenterol. 2013 Mar;6(2):157-67. doi: 10.1177/1756283X12467564.
PubMed 23503324Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, Compher C, Correia I, Higashiguchi T, Holst M, Jensen GL, Malone A, Muscaritoli M, Nyulasi I, Pirlich M, Rothenberg E, Schindler K, Schneider SM, de van der Schueren MA, Sieber C, Valentini L, Yu JC, Van Gossum A, Singer P. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017 Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004. Epub 2016 Sep 14.
PubMed 27642056
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Endoscopic Gastrostomy Versus Percutaneous Endoscopic Gastrostomy With Jejunal Extension: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06717321
- Acronym / sponsor ID
- 23-170
- Conditions
- Aspiration Pneumonias, Tube Feeding, Enteral Feeds
- Keywords
- tube feeds, aspiration pneumonia, peg, peg-J, enteral feeding
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty Enrolling
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Jerry DangUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 5 Dec 2024 (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.
The goal of this clinical trial is to learn if placing a feeding tube with a small bowel extension (called Percutaneous Endoscopic Gastrostomy With Jejunal Extension [PEG-J]) is better at preventing pneumonia than a standard feeding tube (called Percutaneous Endoscopic Gastrostomy [PEG]) in people who need long-term tube feeding. Researchers want to know if people who receive a PEG-J have fewer cases of pneumonia in the first 30 days compared to those who receive a standard PEG, and whether PEG-J tubes require more follow-up procedures to fix tube problems.
Researchers will compare two different types of feeding tubes: a standard feeding tube that goes into the stomach (PEG) versus a feeding tube that extends past the stomach into the small intestine (PEG-J). This will help determine which type of feeding tube is safer and works better for patients.
Participants will be randomly assigned to receive either a PEG or PEG-J feeding tube through a minimally invasive procedure. They will start receiving nutrition through the tube 24 hours after placement and be monitored for 30 days to check for problems like pneumonia or tube malfunction, while receiving regular medical care from their treating doctors.
The study is open to people who are 18 years or older and need a new feeding tube for long-term nutrition. People cannot take part if they have pneumonia, COVID-19, an existing feeding tube, previous stomach surgery, gastroparesis (a condition affecting stomach movement), digestive system blockage, are pregnant, or are in prison. All participants must understand English.
Participation is voluntary, and participants can leave the study at any time. The study team will carefully monitor all participants for any problems throughout the 30-day period
Detailed description
This randomized clinical trial investigates the comparative efficacy of percutaneous endoscopic gastrostomy (PEG) versus percutaneous endoscopic gastrostomy with jejunal extension (PEGJ) for long-term enteral access. The study addresses a critical knowledge gap in the literature regarding the optimal approach for enteral feeding in patients at risk for aspiration.
Current evidence suggests that aspiration pneumonia occurs in up to 30% of patients following PEG placement, with some studies demonstrating aspiration in up to 38% of patients immediately after enteral feeding administration. This high rate is hypothesized to result from gastric reflux. While PEGJ has been proposed as a potential solution by advancing feeds beyond the pylorus, existing evidence consists primarily of small case series and retrospective studies, with reported aspiration pneumonia rates of approximately 10%. However, the methodological limitations of these studies and contradicting findings create uncertainty about the optimal approach.
A recent meta-analysis of enteral feeding in critically ill patients suggested potential benefits of post-pyloric feeding, but included moderate to low quality evidence and did not directly compare PEG versus PEGJ. Furthermore, some researchers argue that aspiration events may result from oropharyngeal dysphagia rather than gastric reflux, potentially limiting the benefit of jejunal extension.
The study employs a prospective, randomized design with 1:1 allocation using distance randomization via RedCap to ensure allocation concealment. Sample size calculation was based on detecting a 20% difference between groups in aspiration pneumonia rates, with power analysis accounting for a statistical power of 0.8 using chi-square test methodology.
The technical aspects of tube placement follow standardized protocols. For PEG placement, a 20-French pull-type tube is positioned using safe track technique with transillumination and 1:1 finger indentation, placing the tube midway between the greater and lesser curves of the stomach. The PEGJ procedure begins similarly but utilizes a 24-French pull-type PEG followed by advancement of a 12-French jejunal extension tube, which is secured to the small bowel wall with endoclips as indicated.
Both groups will receive continuous feeding rather than bolus feeding to standardize the feeding methodology. The study design accounts for potential confounding factors by excluding patients with conditions that might independently affect aspiration risk or tube function, such as gastroparesis or prior upper gastrointestinal surgery.
The research addresses both clinical efficacy and practical considerations, as PEGJ tubes have reported malfunction rates of up to 50%, potentially requiring additional interventions. This prospective investigation will provide high-quality evidence to guide clinical decision-making, balancing the potential benefits of aspiration reduction against the risks of tube dysfunction and need for reintervention.
Statistical analysis will be conducted by an internal biostatistician using appropriate methodologies for both continuous and categorical variables, with adjustments for non-normal distributions when necessary. The study's 30-day follow-up period was selected based on typical timeframes for post-procedure complications and tube-related adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG arm: Patients receiving the 20-French pull-type PEG tube | Active comparator | Procedure: (Arm 1): PEGPEG Arm: Participants receive a 20-French pull-type percutaneous endoscopic gastrostomy tube placed into the stomach using standard safe track technique with transillumination and 1:1 finger indentation. The tube is positioned midway between the greater and lesser curves of the stomach. Continuous tube feeds begin 24 hours after placement. Follow-up period is 30 days. |
| PEG-J arm: Patients receiving the 24-French pull-type PEG with 12-French jejunal extension tube | Active comparator | Procedure: (Arm 2): PEG-JParticipants receive a 24-French pull-type percutaneous endoscopic gastrostomy tube with a 12-French jejunal extension. After standard PEG placement, the jejunal extension tube is advanced past the pylorus and secured to the small bowel wall with endoclips as indicated. Continuous tube feeds begin 24 hours after placement. Follow-up period is 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older
- Requires feeding access as determined by treating provider
Key exclusion criteria (10 listed)
- Concurrent pneumonia at time of enrollment
- Concurrent COVID-19 diagnosis
- Prior feeding access (transabdominal feeding access)
- Prior upper gastrointestinal surgery (previous gastric resection surgery)
- Gastroparesis
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 |
|---|---|---|
| (Arm 1): PEGA 20-French pull type percutaneous endoscopic feeding tube placed into the stomach using endoscopic guidance | Procedure or surgery | PEG arm: Patients receiving the 20-French pull-type PEG tube |
| (Arm 2): PEG-J24-French pull type percutaneous endoscopic feeding tube placed into the stomach with a 12-French jejunal extension tube advanced through the PEG and positioned post-pyloric in the small bowel using endoscopic guidance | Procedure or surgery | PEG-J arm: Patients receiving the 24-French pull-type PEG with 12-French jejunal extension tube |
Primary outcome
Number of Participants Who Developed Post-Procedure Pneumonia
Time frame: From day of procedure (day 0) through 30 days post-procedure
Diagnosis of pneumonia will be determined based on clinical judgment of the treating provider and must be explicitly documented as "pneumonia" in the medical record.
3 secondary outcomes
Number of Participants Requiring Additional Procedures Due to Tube Malfunction
Time frame: From day of procedure (day 0) through 30 days post-procedure
Number of Participants with Post-Operative Complications
Time frame: From day of procedure (day 0) through 30 days post-procedure
Total Procedure Time in Minutes from Start to Completion of Feeding Tube Placement
Time frame: Day of procedure
Results and safety
The study was stopped early (reason given: Difficulty Enrolling). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Background: PubMed 7492001Fox KA, Mularski RA, Sarfati MR, Brooks ME, Warneke JA, Hunter GC, Rappaport WD. Aspiration pneumonia following surgically placed feeding tubes. Am J Surg. 1995 Dec;170(6):564-6; discussion 566-7. doi: 10.1016/s0002-9610(99)80016-6.
- Background: PubMed 30983013Chang WK, Huang HH, Lin HH, Tsai CL. Evaluation of Oropharyngeal Dysphagia in Patients Who Underwent Percutaneous Endoscopic Gastrostomy: Stratification Risk of Pneumonia. JPEN J Parenter Enteral Nutr. 2020 Feb;44(2):239-245. doi: 10.1002/jpen.1592. Epub 2019 Apr 14.
- Background: PubMed 6780678Gauderer MW, Ponsky JL, Izant RJ Jr. Gastrostomy without laparotomy: a percutaneous endoscopic technique. J Pediatr Surg. 1980 Dec;15(6):872-5. doi: 10.1016/s0022-3468(80)80296-x.
- Background: PubMed 17119170Minard G. The history of surgically placed feeding tubes. Nutr Clin Pract. 2006 Dec;21(6):626-33. doi: 10.1177/0115426506021006626.
- Background: PubMed 23503324Seres DS, Valcarcel M, Guillaume A. Advantages of enteral nutrition over parenteral nutrition. Ther Adv Gastroenterol. 2013 Mar;6(2):157-67. doi: 10.1177/1756283X12467564.
- Background: PubMed 27642056Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, Compher C, Correia I, Higashiguchi T, Holst M, Jensen GL, Malone A, Muscaritoli M, Nyulasi I, Pirlich M, Rothenberg E, Schindler K, Schneider SM, de van der Schueren MA, Sieber C, Valentini L, Yu JC, Van Gossum A, Singer P. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017 Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004. Epub 2016 Sep 14.
- Individual participant dataSharing planned: No. Based on the protocol's data collection and privacy sections, individual participant data (IPD) that underlie the results reported in published articles will not be shared. The IRB-approved protocol specifies that data access is restricted to the research team and regulatory instances at Cleveland Clinic. As per protocol's privacy and confidentiality section, data will be safeguarded in REDCap with access limited to authorized study personnel, and data retention is specified for 5 years after study completion. These limitations on data sharing are in place to maintain participant confidentiality and comply with the privacy protections promised during the informed consent process.
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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.
Jerry Dang, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (Arm 1): PEG and (Arm 2): PEG-J in people with Aspiration Pneumonias and Tube Feeding, run by Jerry Dang at 1 site in United States.
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 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2025. 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 States. 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 was stopped early (reason given: Difficulty Enrolling). Results are not available in the source record.
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?
Number of Participants Who Developed Post-Procedure Pneumonia (time frame: From day of procedure (day 0) through 30 days 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 NCT06717321, which also lists 6 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 6 Aug 2025.