Hirschsprung DiseaseBIOPSYNCT05307419
Full Thickness vs. Rectal Suction Biopsy in the Diagnosis of Hirschsprungs Disease
A study testing Rectal suction biopsy. and Full-thickness rectal biopsy. in people with Hirschsprung Disease, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The objective of this prospective study is to compare the diagnostic accuracy of rectal suction biopsy (RSB) compared to full thickness rectal biopsy (FTB) in the diagnosis of Hirschsprungs Disease (HD) in children. The secondary objective to compare cost-effectiveness of the two procedures Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Hirschsprung Disease
- What is being tested?
- Rectal suction biopsy. and Full-thickness rectal biopsy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2022to 1 Feb 2024
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients that are referred for rectal biopsy for suspected HD, age 0-15 years.
- Written informed consent of the parents or guardian.
Who cannot join
- Lack of consent from parents or guardians.
- Previous surgery on the ano-rectum e.g. crohns disease and/or fistulas
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, Fyn, 5000
Niels mr Bjorn, Dr, +4523241781, niels.bjorn@rsyd.dk
Mark mr Ellebaek, Dr., +4540880511, mark.ellebaek1@rsyd.dk
About this study
Official title: Prospective Randomised Blinded Study Comparing Full Thickness Biopsy and Rectal Suction Biopsies in the Diagnosis of Mb: Hirschsprung
The objective of this prospective study is to compare the diagnostic accuracy of rectal suction biopsy (RSB) compared to full thickness rectal biopsy (FTB) in the diagnosis of Hirschsprungs Disease (HD) in children. The secondary objective to compare cost-effectiveness of the two procedures
Read the detailed description
Diagnostic procedures involving the need of surgically obtaining tissue material, carry the risk of complications and the risk of being inconclusive due to various reasons. Lowering the risk of inconclusive diagnostic tests with highest sensitivity and specificity is of high importance in all diagnostic procedures.
A full thickness rectal biopsy (FTB) includes both the submucosal and the myenteric nerve plexus for histological evaluation for presence of ganglion cells and hypertrophic nerve fibers. FTB is performed in general anesthesia (GA), the biopsy is cut with scissors under direct visualization of the intestine and with suturing of the biopsy defect. The other method is a suction biopsy (RSB) in which the biopsy is more superficial acquiring only the submucosal layers. RSB's are performed with a specially designed rectoscope, and the biopsy is obtained under negative pressure within the scope, without visual guidance. This procedure can be performed without anesthesia in children blow 1 year and does not necessitate suturing of the bowel.
The problem with especially RSB could be that the biopsy is too superficial or too small in size for proper pathological evaluation. As a consequence the child has to undergo a new procedure. There is also the risk of false positive or false negative results, which is a serious clinical issue carrying the risk of performing extensive surgery in an otherwise healthy child.
Inconclusive biopsies differ extensively from series to series. But the two largest studies show a rate of inconclusive biopsies at 10% for RSB and 5% for FTB.(Freidmacher and Bjorn). The biopsy profile is similar with less than 1% severe complications (Above Clavien DindoIII) in both procedures, with bleeding as dominating in RSB and Fever in FTB.
Thus there are different advantages and disadvantages between the two methods of biopsy in children suspicious of HD, and different centers advocate either. A prospective comparison of both methods with the child as its own control is a more precise way to compare the two methods and has never been performed. Thus, this study is expected to give an answer to an important research question that will have potential implication worldwide.
Hypothesis:
Our hypothesis is that FTB has lower rate of inconclusive biopsies compared to RSB in the diagnosis of HD.
Design:
Prospective, biopsy sample randomised study.
Method:
Patients referred for rectal biopsy at Odense University Hospital on the suspicion of HD will undergo both an FTB and RSB performed under GA in the same procedure.
Patients will be randomised to which biopsy will be examined first at the pathology department. If a diagnosis can bed securely made on the first tissue samples the other biopsy materials will be stores for examination by another pathologist 30 days later. If any nerve cell is present the sample is negative for Mb. Hirschsprung. If no nervecells is present the biopsy the patient is positive for mb. Hirschsprung. If the tissue is evaluated as not suitable for diagnosis the sample is inconclusive. If the sample is inconclusive the tissue from the other biopsy method is evaluated immediately to secure a fast diagnosis.
All children between 0-15 years of age undergoing biopsies for diagnosis of the diagnosis of HD in Western Denmark from 1/9 2020 will be offered to participate and parental accept will be acquired.
Cost-effectiveness will be measured upon with data from pathology cost and surgery utensils cost.
These will be compared between the two groups.
Power calculation:
With the assumption of a 5 % inconclusive rate for FTB and 10% for RSB (2,5) a McNemar's test for matched comparison of dichotomous outcome (inconclusive / conclusive) indicates the need for 282 patients to obtain 70% strength and a significance level of 5%. (P-value 0.05).
These calculations are based on the largest numbers of biopsy evaluations in the literature.
In these publications a rate of 5% inconclusive biopsies at FTB and 10% at RSB are found.
Interim analyse will be performed after 25%, 50% and 75%. Above 8% complications on 30-day follow-up will result in the study will be paused and examinations of the complications will be performed.
- Conditions
- Hirschsprung Disease
- Being tested
- Rectal suction biopsy., Full-thickness rectal biopsy.
- Keywords
- Hirschsprungs disease, Rectal biopsy, Rectal suction biopsy, Full thickness biopsy, Randomised, Blinded, Mb. Hirschsprung
- Medical subject headings
- Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal suction biopsy.Procedure or surgery
Suction biopsy performed
Full-thickness rectal biopsy.Procedure or surgery
Full-thickness biopsy performed
| Study group | Role | What they receive |
|---|---|---|
| Rectal suction biopsy first | Active comparator | Children randomised for pahtological evaluation of rectal suction biopsy tissue first. Receives: Procedure: Rectal suction biopsy.; Procedure: Full-thickness rectal biopsy. |
| Full thickness biopsy first | Active comparator | Children randomised for pathological evaluation of full thickness biopsy tissue first. Receives: Procedure: Rectal suction biopsy.; Procedure: Full-thickness rectal biopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of inconclusive biopsies between FTB and RSB.
Prospective comparison of RSB and FTB when performed on the same patient. Evaluation of diagnostic accuracy.
Measured: 30 days
Secondary outcomes (1)
Surgical and pathology cost.
Cost-effectiveness will be measured from surgical and pathology procedural and utensils costs in euros, between RSB and FTB.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hirschsprung DiseaseStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized blinded case-control study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor
- Investigators
- Mark mr Ellebaek, Dr, Study director, University of Southern DenmarkRasmus mr Nielsen, Dr, Study chair, Odense University HospitalGunvor ms Madsen, Dr, Study chair, Odense University HospitalNiels mr Bjorn, Dr, Principal investigator, Odense University HospitalLene ms Christensen, Dr, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307419
- Sponsor's protocol ID
- S-20190116
- Acronym
- BIOPSY
- Status last verified
- May 2022
- First submitted
- 2 Feb 2022
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muise ED, Hardee S, Morotti RA, Cowles RA. A comparison of suction and full-thickness rectal biopsy in children. J Surg Res. 2016 Mar;201(1):149-55. doi: 10.1016/j.jss.2015.10.031. Epub 2015 Oct 28.
PubMed 26850196Bjorn N, Rasmussen L, Qvist N, Detlefsen S, Ellebaek MB. Full-thickness rectal biopsy in children suspicious for Hirschsprung's disease is safe and yields a low number of insufficient biopsies. J Pediatr Surg. 2018 Oct;53(10):1942-1944. doi: 10.1016/j.jpedsurg.2018.01.005. Epub 2018 Jan 31.
PubMed 29426767Alizai NK, Batcup G, Dixon MF, Stringer MD. Rectal biopsy for Hirschsprung's disease: what is the optimum method? Pediatr Surg Int. 1998 Mar;13(2-3):121-4. doi: 10.1007/s003830050264.
PubMed 9563023Stewart CL, Kulungowski AM, Tong S, Langer JC, Soden J, Somme S. Rectal biopsies for Hirschsprung disease: Patient characteristics by diagnosis and attending specialty. J Pediatr Surg. 2016 Apr;51(4):573-6. doi: 10.1016/j.jpedsurg.2015.10.047. Epub 2015 Oct 19.
PubMed 26592956Friedmacher F, Puri P. Rectal suction biopsy for the diagnosis of Hirschsprung's disease: a systematic review of diagnostic accuracy and complications. Pediatr Surg Int. 2015 Sep;31(9):821-30. doi: 10.1007/s00383-015-3742-8. Epub 2015 Jul 9.
PubMed 26156878Imaizumi T, Murakami H, Nakamura H, Seo S, Koga H, Miyano G, Okawada M, Doi T, Lane GJ, Okazaki T, Arakawa A, Yao T, Yamataka A. Rectal mucosal/submucosal biopsy under general anesthesia ensures optimum diagnosis of bowel motility disorders. Pediatr Surg Int. 2016 Dec;32(12):1173-1176. doi: 10.1007/s00383-016-3976-0. Epub 2016 Sep 23.
PubMed 27663688Pini-Prato A, Martucciello G, Jasonni V. Rectal suction biopsy in the diagnosis of intestinal dysganglionoses: 5-year experience with Solo-RBT in 389 patients. J Pediatr Surg. 2006 Jun;41(6):1043-8. doi: 10.1016/j.jpedsurg.2006.01.070.
PubMed 16769331Ali AE, Morecroft JA, Bowen JC, Bruce J, Morabito A. Wall or machine suction rectal biopsy for Hirschsprung's disease: a simple modified technique can improve the adequacy of biopsy. Pediatr Surg Int. 2006 Aug;22(8):681-2. doi: 10.1007/s00383-006-1714-8. Epub 2006 Jul 4.
PubMed 16821022Hall NJ, Kufeji D, Keshtgar A. Out with the old and in with the new: a comparison of rectal suction biopsies with traditional and modern biopsy forceps. J Pediatr Surg. 2009 Feb;44(2):395-8. doi: 10.1016/j.jpedsurg.2008.10.093.
PubMed 19231542De Lorijn F, Reitsma JB, Voskuijl WP, Aronson DC, Ten Kate FJ, Smets AM, Taminiau JA, Benninga MA. Diagnosis of Hirschsprung's disease: a prospective, comparative accuracy study of common tests. J Pediatr. 2005 Jun;146(6):787-92. doi: 10.1016/j.jpeds.2005.01.044.
PubMed 15973319Bjorn N, Madsen G, Nielsen RG, Pedersen AK, Qvist N, Ellebaek MB. Full-thickness versus rectal suction biopsy for the diagnosis of Hirschsprung's disease: study protocol for a prospective, randomized open-label, within-patient crossover trail. Trials. 2026 May 30. doi: 10.1186/s13063-026-09817-x. Online ahead of print.
PubMed 42218492
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Blinded Study Comparing Full Thickness Biopsy and Rectal Suction Biopsies in the Diagnosis of Mb: Hirschsprung
- ClinicalTrials.gov ID
- NCT05307419
- Acronym / sponsor ID
- BIOPSY / S-20190116
- Conditions
- Hirschsprung Disease
- Keywords
- Hirschsprungs disease, Rectal biopsy, Rectal suction biopsy, Full thickness biopsy, Randomised, Blinded, Mb. Hirschsprung
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 1 Apr 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.
The objective of this prospective study is to compare the diagnostic accuracy of rectal suction biopsy (RSB) compared to full thickness rectal biopsy (FTB) in the diagnosis of Hirschsprungs Disease (HD) in children. The secondary objective to compare cost-effectiveness of the two procedures
Detailed description
Diagnostic procedures involving the need of surgically obtaining tissue material, carry the risk of complications and the risk of being inconclusive due to various reasons. Lowering the risk of inconclusive diagnostic tests with highest sensitivity and specificity is of high importance in all diagnostic procedures.
A full thickness rectal biopsy (FTB) includes both the submucosal and the myenteric nerve plexus for histological evaluation for presence of ganglion cells and hypertrophic nerve fibers. FTB is performed in general anesthesia (GA), the biopsy is cut with scissors under direct visualization of the intestine and with suturing of the biopsy defect. The other method is a suction biopsy (RSB) in which the biopsy is more superficial acquiring only the submucosal layers. RSB's are performed with a specially designed rectoscope, and the biopsy is obtained under negative pressure within the scope, without visual guidance. This procedure can be performed without anesthesia in children blow 1 year and does not necessitate suturing of the bowel.
The problem with especially RSB could be that the biopsy is too superficial or too small in size for proper pathological evaluation. As a consequence the child has to undergo a new procedure. There is also the risk of false positive or false negative results, which is a serious clinical issue carrying the risk of performing extensive surgery in an otherwise healthy child.
Inconclusive biopsies differ extensively from series to series. But the two largest studies show a rate of inconclusive biopsies at 10% for RSB and 5% for FTB.(Freidmacher and Bjorn). The biopsy profile is similar with less than 1% severe complications (Above Clavien DindoIII) in both procedures, with bleeding as dominating in RSB and Fever in FTB.
Thus there are different advantages and disadvantages between the two methods of biopsy in children suspicious of HD, and different centers advocate either. A prospective comparison of both methods with the child as its own control is a more precise way to compare the two methods and has never been performed. Thus, this study is expected to give an answer to an important research question that will have potential implication worldwide.
Hypothesis:
Our hypothesis is that FTB has lower rate of inconclusive biopsies compared to RSB in the diagnosis of HD.
Design:
Prospective, biopsy sample randomised study.
Method:
Patients referred for rectal biopsy at Odense University Hospital on the suspicion of HD will undergo both an FTB and RSB performed under GA in the same procedure.
Patients will be randomised to which biopsy will be examined first at the pathology department. If a diagnosis can bed securely made on the first tissue samples the other biopsy materials will be stores for examination by another pathologist 30 days later. If any nerve cell is present the sample is negative for Mb. Hirschsprung. If no nervecells is present the biopsy the patient is positive for mb. Hirschsprung. If the tissue is evaluated as not suitable for diagnosis the sample is inconclusive. If the sample is inconclusive the tissue from the other biopsy method is evaluated immediately to secure a fast diagnosis.
All children between 0-15 years of age undergoing biopsies for diagnosis of the diagnosis of HD in Western Denmark from 1/9 2020 will be offered to participate and parental accept will be acquired.
Cost-effectiveness will be measured upon with data from pathology cost and surgery utensils cost.
These will be compared between the two groups.
Power calculation:
With the assumption of a 5 % inconclusive rate for FTB and 10% for RSB (2,5) a McNemar's test for matched comparison of dichotomous outcome (inconclusive / conclusive) indicates the need for 282 patients to obtain 70% strength and a significance level of 5%. (P-value 0.05).
These calculations are based on the largest numbers of biopsy evaluations in the literature.
In these publications a rate of 5% inconclusive biopsies at FTB and 10% at RSB are found.
Interim analyse will be performed after 25%, 50% and 75%. Above 8% complications on 30-day follow-up will result in the study will be paused and examinations of the complications will be performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized blinded case-control study.
| Arm | Type | Receives |
|---|---|---|
| Rectal suction biopsy first | Active comparator | Procedure: Rectal suction biopsy., Procedure: Full-thickness rectal biopsy.Children randomised for pahtological evaluation of rectal suction biopsy tissue first. |
| Full thickness biopsy first | Active comparator | Procedure: Rectal suction biopsy., Procedure: Full-thickness rectal biopsy.Children randomised for pathological evaluation of full thickness biopsy tissue first. |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients that are referred for rectal biopsy for suspected HD, age 0-15 years.
- Written informed consent of the parents or guardian.
Key exclusion criteria (2 listed)
- Lack of consent from parents or guardians.
- Previous surgery on the ano-rectum e.g. crohns disease and/or fistulas
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 |
|---|---|---|
| Rectal suction biopsy.Suction biopsy performed | Procedure or surgery | Full thickness biopsy first, Rectal suction biopsy first |
| Full-thickness rectal biopsy.Full-thickness biopsy performed | Procedure or surgery | Full thickness biopsy first, Rectal suction biopsy first |
Primary outcome
Number of inconclusive biopsies between FTB and RSB.
Time frame: 30 days
Prospective comparison of RSB and FTB when performed on the same patient. Evaluation of diagnostic accuracy.
1 secondary outcome
Surgical and pathology cost.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Background: PubMed 26850196Muise ED, Hardee S, Morotti RA, Cowles RA. A comparison of suction and full-thickness rectal biopsy in children. J Surg Res. 2016 Mar;201(1):149-55. doi: 10.1016/j.jss.2015.10.031. Epub 2015 Oct 28.
- Background: PubMed 29426767Bjorn N, Rasmussen L, Qvist N, Detlefsen S, Ellebaek MB. Full-thickness rectal biopsy in children suspicious for Hirschsprung's disease is safe and yields a low number of insufficient biopsies. J Pediatr Surg. 2018 Oct;53(10):1942-1944. doi: 10.1016/j.jpedsurg.2018.01.005. Epub 2018 Jan 31.
- Background: PubMed 9563023Alizai NK, Batcup G, Dixon MF, Stringer MD. Rectal biopsy for Hirschsprung's disease: what is the optimum method? Pediatr Surg Int. 1998 Mar;13(2-3):121-4. doi: 10.1007/s003830050264.
- Background: PubMed 26592956Stewart CL, Kulungowski AM, Tong S, Langer JC, Soden J, Somme S. Rectal biopsies for Hirschsprung disease: Patient characteristics by diagnosis and attending specialty. J Pediatr Surg. 2016 Apr;51(4):573-6. doi: 10.1016/j.jpedsurg.2015.10.047. Epub 2015 Oct 19.
- Background: PubMed 26156878Friedmacher F, Puri P. Rectal suction biopsy for the diagnosis of Hirschsprung's disease: a systematic review of diagnostic accuracy and complications. Pediatr Surg Int. 2015 Sep;31(9):821-30. doi: 10.1007/s00383-015-3742-8. Epub 2015 Jul 9.
- Background: PubMed 27663688Imaizumi T, Murakami H, Nakamura H, Seo S, Koga H, Miyano G, Okawada M, Doi T, Lane GJ, Okazaki T, Arakawa A, Yao T, Yamataka A. Rectal mucosal/submucosal biopsy under general anesthesia ensures optimum diagnosis of bowel motility disorders. Pediatr Surg Int. 2016 Dec;32(12):1173-1176. doi: 10.1007/s00383-016-3976-0. Epub 2016 Sep 23.
- Background: PubMed 16769331Pini-Prato A, Martucciello G, Jasonni V. Rectal suction biopsy in the diagnosis of intestinal dysganglionoses: 5-year experience with Solo-RBT in 389 patients. J Pediatr Surg. 2006 Jun;41(6):1043-8. doi: 10.1016/j.jpedsurg.2006.01.070.
- Background: PubMed 16821022Ali AE, Morecroft JA, Bowen JC, Bruce J, Morabito A. Wall or machine suction rectal biopsy for Hirschsprung's disease: a simple modified technique can improve the adequacy of biopsy. Pediatr Surg Int. 2006 Aug;22(8):681-2. doi: 10.1007/s00383-006-1714-8. Epub 2006 Jul 4.
- Background: PubMed 19231542Hall NJ, Kufeji D, Keshtgar A. Out with the old and in with the new: a comparison of rectal suction biopsies with traditional and modern biopsy forceps. J Pediatr Surg. 2009 Feb;44(2):395-8. doi: 10.1016/j.jpedsurg.2008.10.093.
- Background: PubMed 15973319De Lorijn F, Reitsma JB, Voskuijl WP, Aronson DC, Ten Kate FJ, Smets AM, Taminiau JA, Benninga MA. Diagnosis of Hirschsprung's disease: a prospective, comparative accuracy study of common tests. J Pediatr. 2005 Jun;146(6):787-92. doi: 10.1016/j.jpeds.2005.01.044.
- Derived from this study: PubMed 42218492Bjorn N, Madsen G, Nielsen RG, Pedersen AK, Qvist N, Ellebaek MB. Full-thickness versus rectal suction biopsy for the diagnosis of Hirschsprung's disease: study protocol for a prospective, randomized open-label, within-patient crossover trail. Trials. 2026 May 30. doi: 10.1186/s13063-026-09817-x. Online ahead of print.
- 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.
Mark mr Ellebaek, Dr study director
University of Southern Denmark
Rasmus mr Nielsen, Dr study chair
Odense University Hospital
Gunvor ms Madsen, Dr study chair
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectal suction biopsy. and Full-thickness rectal biopsy. in people with Hirschsprung Disease, run by University of Southern Denmark at 1 site in Denmark.
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 2 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: status not confirmed, as of the sponsor's last update on 17 May 2022. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niels mr Bjorn, Dr (23241781 ext. +45, niels.bjorn@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of inconclusive biopsies between FTB and RSB. (time frame: 30 days). 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 NCT05307419, which also lists 11 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 17 May 2022.