Adenomatous Polyposis ColicoldAPCNCT06435533
Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
A study testing low energy argonplasma coagulation in people with Adenomatous Polyposis Coli and Familial Adenomatous Polyposis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The objective of this study is to investigate the feasibility for the treatment of precancerous peri-ampullary FAP polyps in the duodenum using low-thermal argonplasma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adenomatous Polyposis Coli, Familial Adenomatous Polyposis, Duodenal Adenoma
- What is being tested?
- low energy argonplasma coagulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 6 Dec 2023to 2 Mar 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed FAP disease
- duodenal polyposis with recommendation of a follow-up EGD in 12 months corresponding to stage III (7-8 points) according to Spigelman
- presence of duodenal polyps < 10 mm
- written Informed Consent
Who cannot join
- presence of lesions that are suspicious of the presence of high-grade dysplasia or carcinoma
- pregnancy or breastfeeding
- severe general illnesses (permanent ASA (American Society of Anesthesiologists) III and IV) who do not prognostically benefit from follow-up, life expectancy < 1 year
- severe coagulopathy
- any visible state of duodenal surface that makes APC treatment impossible, e.g. inflammation, stricture, stenosis or scarring changes/scar areas
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Hamburg-Eppendorf
Hamburg, 20246
Thomas Rösch, Professor, +49407410 ext. 50098, t.roesch@uke.de
Tania Ruppenthal, +49407410 ext. 50089, t.ruppenthal@uke.de
About this study
The objective of this study is to investigate the feasibility for the treatment of precancerous peri-ampullary FAP polyps in the duodenum using low-thermal argonplasma.
Read the detailed description
Familial adenomatous polyposis (FAP) is an autosomal dominantly inherited disorder, which results from a germ line mutation in the APC (adenomatous polyposis coli) gene. FAP is characterized by the formation of very high number of colorectal adenomatous polyps which could cause the development of colorectal cancer in the 5th decade of life. After colon surgery patients are still at risk of developing upper GI cancer e.g. in the duodenum. Because of the continuing risk for the development of duodenal cancer, regular endoscopic surveillance is recommended for these patients.
In this study a new APC modality (Precise mode E1) applied for the remission of FAP polyps during routine endoscopic surveillance is suggested. Argonplasma coagulation (APC) is widely used for the ablation and coagulation of superficial lesions in the GI tract. The application of high thermal tissue destroying APC in the duodenum is challenging due to the anatomy of the duodenal wall which is thin and therefore susceptible to thermal damage.
The application of low-thermal argonplasma in the GI tract could be just as useful as it was suggested for the treatment of neoplastic tissue in gynecology. Low-thermal APC using Erbe Standard 3.2 mm FiAPC probe and Precise mode was successfully applied for the remission of cervical intraepithelial neoplasia. The formation of reactive oxygen and nitric oxide species has been discussed as trigger for the effect on neoplasia tissue of low-thermal argonplasma.
Regarding current knowledge this is the first application of this APC modality in the GI tract.
- Being tested
- low energy argonplasma coagulation
- Keywords
- Familial Adenomatous Polyposis, FAP, duodenal adenoma, argon plasma coagulation, Spigelman classification stage III
- Medical subject headings
- Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low energy argonplasma coagulationDevice
Also called cold APC
see above
| Study group | Role | What they receive |
|---|---|---|
| duodenal polyps <10 mm | Experimental | low energy argonplasma coagulation Receives: Device: low energy argonplasma coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
polyp number
Significant reduction in the number of duodenal polyps at the next follow-up appointment
Measured: 12 months
polyp size
Significant reduction in the size of duodenal polyps at the next follow-up appointment
Measured: 12 months
Secondary outcomes (25)
acute haematemesis
rate of acute adverse incidents: bleeding
Measured: 24 hours
acute hemoglobin drop
rate of acute adverse incidents: Hb drop < 2g /dl (grammes per decilitre)
Measured: 24 hours
acute severe hemoglobin drop
rate of acute adverse incidents: Hb drop = or > 2g /dl (grammes per decilitre)
Measured: 24 hours
blood transfusion
rate of acute adverse incidents: Hb drop = or > 2g /dl (grammes per decilitre)
Measured: 24 hours
endoscopic hemostasis
rate of acute adverse incidents: coagulation or clipping
Measured: 24 hours
treatment of perforation
rate of acute adverse incidents: endoscopic clipping
Measured: 24 hours
need for surgical intervention
rate of acute adverse incidents: bleeding or perforation which can not be handled by endoscopic treatment
Measured: 24 hours
acute abdominal pain
rate of acute adverse incidents:pain
Measured: 24 hours
acute dysphagia
rate of acute adverse incidents: stenosis
Measured: 24 hours
acute rise of temperature
rate of acute adverse incidents: fever <38°C (degrees Centigrade)
Measured: 24 hours
EGD (esophago-gastro-duodenoscopy) time
total EGD performing time
Measured: during EGD; up to 45 minutes
therapy time
total ablation time in minutes
Measured: up to 30 minutes
abdominal pain
abdominal pain assessed by patient survey
Measured: 4 days
nausea
nausea assessed by patient survey
Measured: 4 days
feeling of fullness
feeling of fullness assessed by patient survey
Measured: 4 days
emesis
emesis assessed by patient survey
Measured: 4 days
signs of bleeding
hematemesis or tar faeces assessed by patient survey
Measured: 4 days
fever
fever >38°C
Measured: 4 days
need for physician help
visits in doctor's office or hospital
Measured: 4 days
success rate
Change in stage/number of points in Spigelman classification compared to the previous examination
Measured: 12 months
dysphagia
dysphagia caused by duodenal stricture
Measured: 12 months
balloon dilatations
need for endoscopic dilatation of strictured duodenum
Measured: 12 months
abdominal pain
general abdominal pain assessed by patient survey
Measured: 12 months
postprandial pain
postprandial abdominal pain assessed by patient survey
Measured: 12 months
emesis
regurgitation due to duodenal strictures assessed by EGD
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start6 Dec 2023
- Primary completion30 Jan 2025 (estimated)
- Study completion2 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Adenomatous Polyposis ColiStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- peri-ampullary FAP polyps of size smaller than 10 mm will be treated with low energy argonplasma coagulation
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Thomas Rösch, Professor, Principal investigator, Universitätskrankenhaus Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435533
- Sponsor's protocol ID
- 2023-101193-BO-ff
- Other IDs
- 2023
- Acronym
- coldAPC
- Status last verified
- May 2024
- First submitted
- 14 Mar 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aelvoet AS, Buttitta F, Ricciardiello L, Dekker E. Management of familial adenomatous polyposis and MUTYH-associated polyposis; new insights. Best Pract Res Clin Gastroenterol. 2022 Jun-Aug;58-59:101793. doi: 10.1016/j.bpg.2022.101793. Epub 2022 Mar 16.
PubMed 35988966Half E, Bercovich D, Rozen P. Familial adenomatous polyposis. Orphanet J Rare Dis. 2009 Oct 12;4:22. doi: 10.1186/1750-1172-4-22.
PubMed 19822006Ghorbanoghli Z, Bastiaansen BA, Langers AM, Nagengast FM, Poley JW, Hardwick JC, Koornstra JJ, Sanduleanu S, de Vos Tot Nederveen Cappel WH, Witteman BJ, Morreau H, Dekker E, Vasen HF. Extracolonic cancer risk in Dutch patients with APC (adenomatous polyposis coli)-associated polyposis. J Med Genet. 2018 Jan;55(1):11-14. doi: 10.1136/jmedgenet-2017-104545. Epub 2017 May 10.
PubMed 28490611Bulow S, Bjork J, Christensen IJ, Fausa O, Jarvinen H, Moesgaard F, Vasen HF; DAF Study Group. Duodenal adenomatosis in familial adenomatous polyposis. Gut. 2004 Mar;53(3):381-6. doi: 10.1136/gut.2003.027771.
PubMed 14960520Kadmon M, Tandara A, Herfarth C. Duodenal adenomatosis in familial adenomatous polyposis coli. A review of the literature and results from the Heidelberg Polyposis Register. Int J Colorectal Dis. 2001 Apr;16(2):63-75. doi: 10.1007/s003840100290.
PubMed 11355321Bjork J, Akerbrant H, Iselius L, Bergman A, Engwall Y, Wahlstrom J, Martinsson T, Nordling M, Hultcrantz R. Periampullary adenomas and adenocarcinomas in familial adenomatous polyposis: cumulative risks and APC gene mutations. Gastroenterology. 2001 Nov;121(5):1127-35. doi: 10.1053/gast.2001.28707.
PubMed 11677205van Leerdam ME, Roos VH, van Hooft JE, Dekker E, Jover R, Kaminski MF, Latchford A, Neumann H, Pellise M, Saurin JC, Tanis PJ, Wagner A, Balaguer F, Ricciardiello L. Endoscopic management of polyposis syndromes: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2019 Sep;51(9):877-895. doi: 10.1055/a-0965-0605. Epub 2019 Jul 23.
PubMed 31342472Spigelman AD, Williams CB, Talbot IC, Domizio P, Phillips RK. Upper gastrointestinal cancer in patients with familial adenomatous polyposis. Lancet. 1989 Sep 30;2(8666):783-5. doi: 10.1016/s0140-6736(89)90840-4.
PubMed 2571019Manner H. Thermal ablative therapies in the gastrointestinal tract. Curr Opin Gastroenterol. 2023 Sep 1;39(5):370-374. doi: 10.1097/MOG.0000000000000954. Epub 2023 Jun 22.
PubMed 37389449Manner H. Argon plasma coagulation therapy. Curr Opin Gastroenterol. 2008 Sep;24(5):612-6. doi: 10.1097/MOG.0b013e32830bf825.
PubMed 19122503Martusevich AK, Surovegina AV, Bocharin IV, Nazarov VV, Minenko IA, Artamonov MY. Cold Argon Athmospheric Plasma for Biomedicine: Biological Effects, Applications and Possibilities. Antioxidants (Basel). 2022 Jun 27;11(7):1262. doi: 10.3390/antiox11071262.
PubMed 35883753Marzi J, Stope MB, Henes M, Koch A, Wenzel T, Holl M, Layland SL, Neis F, Bosmuller H, Ruoff F, Templin M, Kramer B, Staebler A, Barz J, Carvajal Berrio DA, Enderle M, Loskill PM, Brucker SY, Schenke-Layland K, Weiss M. Noninvasive Physical Plasma as Innovative and Tissue-Preserving Therapy for Women Positive for Cervical Intraepithelial Neoplasia. Cancers (Basel). 2022 Apr 12;14(8):1933. doi: 10.3390/cancers14081933.
PubMed 35454839Grund KE, Storek D, Farin G. Endoscopic argon plasma coagulation (APC) first clinical experiences in flexible endoscopy. Endosc Surg Allied Technol. 1994 Feb;2(1):42-6.
PubMed 8081915Karamanolis G, Triantafyllou K, Tsiamoulos Z, Polymeros D, Kalli T, Misailidis N, Ladas SD. Argon plasma coagulation has a long-lasting therapeutic effect in patients with chronic radiation proctitis. Endoscopy. 2009 Jun;41(6):529-31. doi: 10.1055/s-0029-1214726. Epub 2009 May 13.
PubMed 19440956Peng M, Guo X, Yi F, Shao X, Wang L, Wu Y, Wang C, Zhu M, Bian O, Ibrahim M, Chawla S, Qi X. Endoscopic treatment for gastric antral vascular ectasia. Ther Adv Chronic Dis. 2021 Aug 12;12:20406223211039696. doi: 10.1177/20406223211039696. eCollection 2021.
PubMed 34408826
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
- ClinicalTrials.gov ID
- NCT06435533
- Acronym / sponsor ID
- coldAPC / 2023-101193-BO-ff
- Keywords
- Familial Adenomatous Polyposis, FAP, duodenal adenoma, argon plasma coagulation, Spigelman classification stage III
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 2 Mar 2025 (estimated)
- First posted
- 30 May 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 objective of this study is to investigate the feasibility for the treatment of precancerous peri-ampullary FAP polyps in the duodenum using low-thermal argonplasma.
Detailed description
Familial adenomatous polyposis (FAP) is an autosomal dominantly inherited disorder, which results from a germ line mutation in the APC (adenomatous polyposis coli) gene. FAP is characterized by the formation of very high number of colorectal adenomatous polyps which could cause the development of colorectal cancer in the 5th decade of life. After colon surgery patients are still at risk of developing upper GI cancer e.g. in the duodenum. Because of the continuing risk for the development of duodenal cancer, regular endoscopic surveillance is recommended for these patients.
In this study a new APC modality (Precise mode E1) applied for the remission of FAP polyps during routine endoscopic surveillance is suggested. Argonplasma coagulation (APC) is widely used for the ablation and coagulation of superficial lesions in the GI tract. The application of high thermal tissue destroying APC in the duodenum is challenging due to the anatomy of the duodenal wall which is thin and therefore susceptible to thermal damage.
The application of low-thermal argonplasma in the GI tract could be just as useful as it was suggested for the treatment of neoplastic tissue in gynecology. Low-thermal APC using Erbe Standard 3.2 mm FiAPC probe and Precise mode was successfully applied for the remission of cervical intraepithelial neoplasia. The formation of reactive oxygen and nitric oxide species has been discussed as trigger for the effect on neoplasia tissue of low-thermal argonplasma.
Regarding current knowledge this is the first application of this APC modality in the GI tract.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- peri-ampullary FAP polyps of size smaller than 10 mm will be treated with low energy argonplasma coagulation
| Arm | Type | Receives |
|---|---|---|
| duodenal polyps <10 mm | Experimental | Device: low energy argonplasma coagulationlow energy argonplasma coagulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- confirmed FAP disease
- duodenal polyposis with recommendation of a follow-up EGD in 12 months corresponding to stage III (7-8 points) according to Spigelman
- presence of duodenal polyps < 10 mm
- written Informed Consent
Key exclusion criteria (5 listed)
- presence of lesions that are suspicious of the presence of high-grade dysplasia or carcinoma
- pregnancy or breastfeeding
- severe general illnesses (permanent ASA (American Society of Anesthesiologists) III and IV) who do not prognostically benefit from follow-up, life expectancy < 1 year
- severe coagulopathy
- any visible state of duodenal surface that makes APC treatment impossible, e.g. inflammation, stricture, stenosis or scarring changes/scar areas
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 |
|---|---|---|
| low energy argonplasma coagulationAlso: cold APCsee above | Device | duodenal polyps <10 mm |
Primary outcome
polyp number
Time frame: 12 months
Significant reduction in the number of duodenal polyps at the next follow-up appointment
polyp size
Time frame: 12 months
Significant reduction in the size of duodenal polyps at the next follow-up appointment
25 secondary outcomes
acute haematemesis
Time frame: 24 hours
acute hemoglobin drop
Time frame: 24 hours
acute severe hemoglobin drop
Time frame: 24 hours
blood transfusion
Time frame: 24 hours
endoscopic hemostasis
Time frame: 24 hours
treatment of perforation
Time frame: 24 hours
need for surgical intervention
Time frame: 24 hours
acute abdominal pain
Time frame: 24 hours
acute dysphagia
Time frame: 24 hours
acute rise of temperature
Time frame: 24 hours
EGD (esophago-gastro-duodenoscopy) time
Time frame: during EGD; up to 45 minutes
therapy time
Time frame: up to 30 minutes
abdominal pain
Time frame: 4 days
nausea
Time frame: 4 days
feeling of fullness
Time frame: 4 days
emesis
Time frame: 4 days
signs of bleeding
Time frame: 4 days
fever
Time frame: 4 days
need for physician help
Time frame: 4 days
success rate
Time frame: 12 months
dysphagia
Time frame: 12 months
balloon dilatations
Time frame: 12 months
abdominal pain
Time frame: 12 months
postprandial pain
Time frame: 12 months
emesis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Background: PubMed 35988966Aelvoet AS, Buttitta F, Ricciardiello L, Dekker E. Management of familial adenomatous polyposis and MUTYH-associated polyposis; new insights. Best Pract Res Clin Gastroenterol. 2022 Jun-Aug;58-59:101793. doi: 10.1016/j.bpg.2022.101793. Epub 2022 Mar 16.
- Background: PubMed 19822006Half E, Bercovich D, Rozen P. Familial adenomatous polyposis. Orphanet J Rare Dis. 2009 Oct 12;4:22. doi: 10.1186/1750-1172-4-22.
- Background: PubMed 28490611Ghorbanoghli Z, Bastiaansen BA, Langers AM, Nagengast FM, Poley JW, Hardwick JC, Koornstra JJ, Sanduleanu S, de Vos Tot Nederveen Cappel WH, Witteman BJ, Morreau H, Dekker E, Vasen HF. Extracolonic cancer risk in Dutch patients with APC (adenomatous polyposis coli)-associated polyposis. J Med Genet. 2018 Jan;55(1):11-14. doi: 10.1136/jmedgenet-2017-104545. Epub 2017 May 10.
- Background: PubMed 14960520Bulow S, Bjork J, Christensen IJ, Fausa O, Jarvinen H, Moesgaard F, Vasen HF; DAF Study Group. Duodenal adenomatosis in familial adenomatous polyposis. Gut. 2004 Mar;53(3):381-6. doi: 10.1136/gut.2003.027771.
- Background: PubMed 11355321Kadmon M, Tandara A, Herfarth C. Duodenal adenomatosis in familial adenomatous polyposis coli. A review of the literature and results from the Heidelberg Polyposis Register. Int J Colorectal Dis. 2001 Apr;16(2):63-75. doi: 10.1007/s003840100290.
- Background: PubMed 11677205Bjork J, Akerbrant H, Iselius L, Bergman A, Engwall Y, Wahlstrom J, Martinsson T, Nordling M, Hultcrantz R. Periampullary adenomas and adenocarcinomas in familial adenomatous polyposis: cumulative risks and APC gene mutations. Gastroenterology. 2001 Nov;121(5):1127-35. doi: 10.1053/gast.2001.28707.
- Background: PubMed 31342472van Leerdam ME, Roos VH, van Hooft JE, Dekker E, Jover R, Kaminski MF, Latchford A, Neumann H, Pellise M, Saurin JC, Tanis PJ, Wagner A, Balaguer F, Ricciardiello L. Endoscopic management of polyposis syndromes: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2019 Sep;51(9):877-895. doi: 10.1055/a-0965-0605. Epub 2019 Jul 23.
- Background: PubMed 2571019Spigelman AD, Williams CB, Talbot IC, Domizio P, Phillips RK. Upper gastrointestinal cancer in patients with familial adenomatous polyposis. Lancet. 1989 Sep 30;2(8666):783-5. doi: 10.1016/s0140-6736(89)90840-4.
- Background: PubMed 37389449Manner H. Thermal ablative therapies in the gastrointestinal tract. Curr Opin Gastroenterol. 2023 Sep 1;39(5):370-374. doi: 10.1097/MOG.0000000000000954. Epub 2023 Jun 22.
- Background: PubMed 19122503Manner H. Argon plasma coagulation therapy. Curr Opin Gastroenterol. 2008 Sep;24(5):612-6. doi: 10.1097/MOG.0b013e32830bf825.
- Background: PubMed 35883753Martusevich AK, Surovegina AV, Bocharin IV, Nazarov VV, Minenko IA, Artamonov MY. Cold Argon Athmospheric Plasma for Biomedicine: Biological Effects, Applications and Possibilities. Antioxidants (Basel). 2022 Jun 27;11(7):1262. doi: 10.3390/antiox11071262.
- Background: PubMed 35454839Marzi J, Stope MB, Henes M, Koch A, Wenzel T, Holl M, Layland SL, Neis F, Bosmuller H, Ruoff F, Templin M, Kramer B, Staebler A, Barz J, Carvajal Berrio DA, Enderle M, Loskill PM, Brucker SY, Schenke-Layland K, Weiss M. Noninvasive Physical Plasma as Innovative and Tissue-Preserving Therapy for Women Positive for Cervical Intraepithelial Neoplasia. Cancers (Basel). 2022 Apr 12;14(8):1933. doi: 10.3390/cancers14081933.
- German oncological guidelines for colorectal cancerLink provided by the sponsor.
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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.
Thomas Rösch, Professor principal investigator
Universitätskrankenhaus Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low energy argonplasma coagulation in people with Adenomatous Polyposis Coli and Familial Adenomatous Polyposis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 4 inclusion and 5 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 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 Thomas Rösch, Professor (+49407410 ext. 50098, t.roesch@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
polyp number (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT06435533, which also lists 24 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 30 May 2024.