Bariatric Surgery CandidateBartélémisNCT03834181
Evaluation of a Telemedicine System for Patients Carried for Bariatric Surgery
A study testing Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b" in people with Bariatric Surgery Candidate, run by IHU Strasbourg at 1 site in France.
Trial summary
This study is intended to study the feasibility of a telemedicine system to monitor and control certain vital parameters before and after surgery for obesity. During the preoperative preparation phase, weight, exercise, blood pressure and heart rate are recorded and transmitted to the patient's surgeon. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2019to 31 Aug 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient (s) applying for bariatric surgery
- Patient aged 18 to 65
- Compliance with the High Authority of Health (HAS) criteria:
- BMI> 40 without comorbidities
- BMI> 35 with cardiovascular, metabolic, respiratory or rheumatic comorbidity,
- Psychological follow-up well followed for 4 to 6 months
Show all 11Show fewer
- Patient with an ASA (American Society of Anesthesiologists) score less than or equal to 2
- Patient able to receive and understand information about the study
- Patient able to manipulate connected objects
- Patient (e) affiliated to the French social security system
- Patient who does not live in the white area of wireless telephone coverage.
Who cannot join
- Patient unable to give informed consent
- Patient unable to use the connected tools (Internet)
- Patient whose general condition is not favorable to participation in the study
- Patient presenting, in the opinion of the investigator, a condition that may prevent participation in the procedures provided for in the study
- Patient in exclusion period (determined by previous or current study)
- Patient under the protection of justice
Show all 13Show fewer
- Patient under guardianship or trusteeship
- Patient with epilepsy
- Patient who is sensitive to light flashes
- Patient with deformity of the ear
- Patient with bleeding ear
- Patient whose home is in a white GSM (Global System for Mobile Communications) zone or white zone in reception and 3G (third generation) transmission
- Patient (e) not knowing how to use connected objects.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Digestive et Endocrinienne, NHC
Strasbourg, 67 091
About this study
This study is intended to study the feasibility of a telemedicine system to monitor and control certain vital parameters before and after surgery for obesity. During the preoperative preparation phase, weight, exercise, blood pressure and heart rate are recorded and transmitted to the patient's surgeon. In the immediate post operative period, the heart rate is a sensitive and reliable indicator of the occurrence of a complication. A telemetry system will allow rapid home return, continuous monitoring and early warning in the event of a problem. Prolonged follow-up identical to that started preoperatively should allow improvement and better control of weight loss by monitoring especially physical exercise.
Read the detailed description
The evolution of the health system requires a rationalization of the supply of care and the care of patients. It has allowed the evolution and generalization of ambulatory surgery for certain pathologies. For other pathologies, a hospital stay is still desirable with a tendency to decrease the length of stay. Thanks to the telemedicine platforms, specialized medical monitoring can be extended pre- and post-operatively to ensure good patient preparation and quality secure follow-up.
Early return to home is an essential parameter in optimizing the distribution of hospital resources. Several studies have shown improved clinical outcomes, fewer complications, more beds available, and lower hospital costs. The development of outpatient surgery has enabled the establishment of systems allowing a return home in secure conditions. Early return home is also a wish of the patient. He becomes an actor of his own health. Obesity surgery is an exemplary specialty for the care of patients. The ideal course of care is perfectly codified both preoperatively and postoperatively. Nevertheless, this ideal care path is not always respected especially in structures too small to offer a real integrated multidisciplinary follow-up. Pre- and postoperative management solutions on the Internet exist but require a voluntary and active adherence of the patient. They allow a stronger involvement of the patient in his approach, they are nascent and integrate no connected solution for automated monitoring of the patient. Telemedicine can now allow continuous monitoring without the need for face-to-face interaction. The automatic collection of the physical activity and the heart rate makes it possible to guarantee the involvement of the patient in his preparation. After the intervention, the monitoring of the occurrence of complications can be delegated to connected objects with alert transmission according to parameters defined in advance. In particular, the heart rate is a sensitive indicator and will be followed by two sensors (activity bracelet and pulse oximeter). These complications occur mainly in the 15 days following the intervention, they are rare in immediate postoperative. The hospital stay is no longer necessary for a simple surveillance. In case of receipt of an alert, the surgeon contacts the patient to check his state of health. An adapted action is then engaged.
The late postoperative follow-up throughout this document corresponds to the phase following the immediate postoperative phase. This late postoperative follow-up can be improved with the support of telemonitoring (activity, change in weight.) The addition of connected devices allows a stronger and faster interaction between the patient and his doctors, providing close monitoring and appropriate support.
The study focuses on assessing the reliability of a remote monitoring system. The implementation of this remote monitoring system is subordinated to the reliability of the data transmissions between the connected objects and the remote site which receives the data, interprets them and generates the alerts.
The motivation of the patient is appreciated by the acceptance of connected objects.
During this study, the remote monitoring system is offered in addition to the usual care. The usual care does not change and is not impaired. This study concerns only one group of patients, there is no control group since the investigators seek to validate the reliability of remote surveillance.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b"
- Keywords
- Connected devices, Telemetry, Obesity surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b"Device
All patients will be monitored before and after the bariatric surgery:
- During the preoperative preparation phase: weight, exercise, blood pressure and heart rate
- In the immediate post operative period: continuous monitoring of the heart rate with a telemetry system
- Prolonged follow-up: weight, exercise, blood pressure and heart rate
| Study group | Role | What they receive |
|---|---|---|
| Monitoring evaluation | Experimental | Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b" Receives: Device: Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of a remote monitoring system during treatment for bariatric surgery evaluated in days between two failures
The reliability of the system, corresponding to the average time between two failures, over the 9 months of study for each of the 30 patients. A failure is a momentary and abrupt loss of the ability of the system to transmit data.
Measured: From the inclusion to 6 months after the surgery
Secondary outcomes (4)
Patient acceptance of adding a telemonitoring device to their care evaluated in percentage of patients who signed a consent
Acceptance is the ratio of the number of patients who signed the consent to the number of total patients to whom the study was presented as a percentage.
Measured: Inclusion period of 4 months
Relevance of the data received from each connected object (activity bracelet, scales, blood pressure monitor, thermometer and pulse oximeter) evaluated in percentage of data sent and verified
The relevance of the data corresponds to the number of data sent and verified, using the alert system, of each of the connected objects (activity bracelet, scales, blood pressure monitor, thermometer and pulse oximeter) the number of data sent by the system over the entire duration of the study (activity bracelet, scale, tensiometer) or the entire immediate postoperative period (thermometer, pulse oximeter), in percentage.
Measured: Study duration of 18 months
Durability of the data over a defined period evaluated in number of connections.
The durability of the data corresponds to the number of connections interrupted or lost in a duration of more than 90 minutes per patient
Measured: From the inclusion to 6 months after the surgery
Ratio of the number of patients who performed all the prescribed autonomic measures requested on the total number of patients included in the study
Ratio of the number of patients who performed all the prescribed autonomic measures requested on the total number of patients included in the study, as a percentage. It will be evaluated by age categories (18-24, 25-34, 35-44, 45-54, 54-65 years), sex (male and female) and obesity classes (35.00 ≤ BMI). ≤ 39.99 kg / m² and BMI ≥ 40.00 kg / m²)
Measured: Study duration of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start15 Apr 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
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 Bariatric Surgery CandidateStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Vix, MD, Principal investigator, Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834181
- Sponsor's protocol ID
- 18-003
- Acronym
- Bartélémis
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loots E, Sartorius B, Paruk IM, Clarke DL. The Successful Implementation of a Modified Enhanced Recovery After Surgery (ERAS) Program for Bariatric Surgery in a South African Teaching Hospital. Surg Laparosc Endosc Percutan Tech. 2018 Feb;28(1):26-29. doi: 10.1097/SLE.0000000000000488.
PubMed 29064879Lemanu DP, Singh PP, Berridge K, Burr M, Birch C, Babor R, MacCormick AD, Arroll B, Hill AG. Randomized clinical trial of enhanced recovery versus standard care after laparoscopic sleeve gastrectomy. Br J Surg. 2013 Mar;100(4):482-9. doi: 10.1002/bjs.9026. Epub 2013 Jan 21.
PubMed 23339040Jonsson A, Lin E, Patel L, Patel AD, Stetler JL, Prayor-Patterson H, Singh A, Srinivasan JK, Sweeney JF, Davis SS Jr. Barriers to Enhanced Recovery after Surgery after Laparoscopic Sleeve Gastrectomy. J Am Coll Surg. 2018 Apr;226(4):605-613. doi: 10.1016/j.jamcollsurg.2017.12.028. Epub 2018 Jan 5.
PubMed 29309941Aman MW, Stem M, Schweitzer MA, Magnuson TH, Lidor AO. Early hospital readmission after bariatric surgery. Surg Endosc. 2016 Jun;30(6):2231-8. doi: 10.1007/s00464-015-4483-4. Epub 2015 Oct 19.
PubMed 26482158Kampmeijer R, Pavlova M, Tambor M, Golinowska S, Groot W. The use of e-health and m-health tools in health promotion and primary prevention among older adults: a systematic literature review. BMC Health Serv Res. 2016 Sep 5;16 Suppl 5(Suppl 5):290. doi: 10.1186/s12913-016-1522-3.
PubMed 27608677Wang Y, Xue H, Huang Y, Huang L, Zhang D. A Systematic Review of Application and Effectiveness of mHealth Interventions for Obesity and Diabetes Treatment and Self-Management. Adv Nutr. 2017 May 15;8(3):449-462. doi: 10.3945/an.116.014100. Print 2017 May.
PubMed 28507010Chen SY, Stem M, Schweitzer MA, Magnuson TH, Lidor AO. Assessment of postdischarge complications after bariatric surgery: A National Surgical Quality Improvement Program analysis. Surgery. 2015 Sep;158(3):777-86. doi: 10.1016/j.surg.2015.04.028. Epub 2015 Jun 19.
PubMed 26096563Montravers P, Augustin P, Zappella N, Dufour G, Arapis K, Chosidow D, Fournier P, Ribeiro-Parienti L, Marmuse JP, Desmard M. Diagnosis and management of the postoperative surgical and medical complications of bariatric surgery. Anaesth Crit Care Pain Med. 2015 Feb;34(1):45-52. doi: 10.1016/j.accpm.2014.06.002. Epub 2015 Mar 5.
PubMed 25829315
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Telemedicine System for Patients Carried for Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03834181
- Acronym / sponsor ID
- Bartélémis / 18-003
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Connected devices, Telemetry, Obesity surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 7 Feb 2019 (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.
This study is intended to study the feasibility of a telemedicine system to monitor and control certain vital parameters before and after surgery for obesity. During the preoperative preparation phase, weight, exercise, blood pressure and heart rate are recorded and transmitted to the patient's surgeon. In the immediate post operative period, the heart rate is a sensitive and reliable indicator of the occurrence of a complication. A telemetry system will allow rapid home return, continuous monitoring and early warning in the event of a problem. Prolonged follow-up identical to that started preoperatively should allow improvement and better control of weight loss by monitoring especially physical exercise.
Detailed description
The evolution of the health system requires a rationalization of the supply of care and the care of patients. It has allowed the evolution and generalization of ambulatory surgery for certain pathologies. For other pathologies, a hospital stay is still desirable with a tendency to decrease the length of stay. Thanks to the telemedicine platforms, specialized medical monitoring can be extended pre- and post-operatively to ensure good patient preparation and quality secure follow-up.
Early return to home is an essential parameter in optimizing the distribution of hospital resources. Several studies have shown improved clinical outcomes, fewer complications, more beds available, and lower hospital costs. The development of outpatient surgery has enabled the establishment of systems allowing a return home in secure conditions. Early return home is also a wish of the patient. He becomes an actor of his own health. Obesity surgery is an exemplary specialty for the care of patients. The ideal course of care is perfectly codified both preoperatively and postoperatively. Nevertheless, this ideal care path is not always respected especially in structures too small to offer a real integrated multidisciplinary follow-up. Pre- and postoperative management solutions on the Internet exist but require a voluntary and active adherence of the patient. They allow a stronger involvement of the patient in his approach, they are nascent and integrate no connected solution for automated monitoring of the patient. Telemedicine can now allow continuous monitoring without the need for face-to-face interaction. The automatic collection of the physical activity and the heart rate makes it possible to guarantee the involvement of the patient in his preparation. After the intervention, the monitoring of the occurrence of complications can be delegated to connected objects with alert transmission according to parameters defined in advance. In particular, the heart rate is a sensitive indicator and will be followed by two sensors (activity bracelet and pulse oximeter). These complications occur mainly in the 15 days following the intervention, they are rare in immediate postoperative. The hospital stay is no longer necessary for a simple surveillance. In case of receipt of an alert, the surgeon contacts the patient to check his state of health. An adapted action is then engaged.
The late postoperative follow-up throughout this document corresponds to the phase following the immediate postoperative phase. This late postoperative follow-up can be improved with the support of telemonitoring (activity, change in weight.) The addition of connected devices allows a stronger and faster interaction between the patient and his doctors, providing close monitoring and appropriate support.
The study focuses on assessing the reliability of a remote monitoring system. The implementation of this remote monitoring system is subordinated to the reliability of the data transmissions between the connected objects and the remote site which receives the data, interprets them and generates the alerts.
The motivation of the patient is appreciated by the acceptance of connected objects.
During this study, the remote monitoring system is offered in addition to the usual care. The usual care does not change and is not impaired. This study concerns only one group of patients, there is no control group since the investigators seek to validate the reliability of remote surveillance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring evaluation | Experimental | Device: Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b"Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b" |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient (s) applying for bariatric surgery
- Patient aged 18 to 65
- Compliance with the High Authority of Health (HAS) criteria:
- Patient with an ASA (American Society of Anesthesiologists) score less than or equal to 2
- Patient able to receive and understand information about the study
Key exclusion criteria (13 listed)
- Patient unable to give informed consent
- Patient unable to use the connected tools (Internet)
- Patient whose general condition is not favorable to participation in the study
- Patient presenting, in the opinion of the investigator, a condition that may prevent participation in the procedures provided for in the study
- Patient in exclusion period (determined by previous or current study)
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 |
|---|---|---|
| Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b"All patients will be monitored before and after the bariatric surgery: * During the preoperative preparation phase: weight, exercise, blood pressure and heart rate * In the immediate post operative period: continuous monitoring of the heart rate with a telemetry system * Prolonged follow-up: weight, exercise, blood pressure and heart rate | Device | Monitoring evaluation |
Primary outcome
Reliability of a remote monitoring system during treatment for bariatric surgery evaluated in days between two failures
Time frame: From the inclusion to 6 months after the surgery
The reliability of the system, corresponding to the average time between two failures, over the 9 months of study for each of the 30 patients. A failure is a momentary and abrupt loss of the ability of the system to transmit data.
4 secondary outcomes
Patient acceptance of adding a telemonitoring device to their care evaluated in percentage of patients who signed a consent
Time frame: Inclusion period of 4 months
Relevance of the data received from each connected object (activity bracelet, scales, blood pressure monitor, thermometer and pulse oximeter) evaluated in percentage of data sent and verified
Time frame: Study duration of 18 months
Durability of the data over a defined period evaluated in number of connections.
Time frame: From the inclusion to 6 months after the surgery
Ratio of the number of patients who performed all the prescribed autonomic measures requested on the total number of patients included in the study
Time frame: Study duration of 18 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 10 Feb 2021.
- Background: PubMed 29064879Loots E, Sartorius B, Paruk IM, Clarke DL. The Successful Implementation of a Modified Enhanced Recovery After Surgery (ERAS) Program for Bariatric Surgery in a South African Teaching Hospital. Surg Laparosc Endosc Percutan Tech. 2018 Feb;28(1):26-29. doi: 10.1097/SLE.0000000000000488.
- Background: PubMed 23339040Lemanu DP, Singh PP, Berridge K, Burr M, Birch C, Babor R, MacCormick AD, Arroll B, Hill AG. Randomized clinical trial of enhanced recovery versus standard care after laparoscopic sleeve gastrectomy. Br J Surg. 2013 Mar;100(4):482-9. doi: 10.1002/bjs.9026. Epub 2013 Jan 21.
- Background: PubMed 29309941Jonsson A, Lin E, Patel L, Patel AD, Stetler JL, Prayor-Patterson H, Singh A, Srinivasan JK, Sweeney JF, Davis SS Jr. Barriers to Enhanced Recovery after Surgery after Laparoscopic Sleeve Gastrectomy. J Am Coll Surg. 2018 Apr;226(4):605-613. doi: 10.1016/j.jamcollsurg.2017.12.028. Epub 2018 Jan 5.
- Background: PubMed 26482158Aman MW, Stem M, Schweitzer MA, Magnuson TH, Lidor AO. Early hospital readmission after bariatric surgery. Surg Endosc. 2016 Jun;30(6):2231-8. doi: 10.1007/s00464-015-4483-4. Epub 2015 Oct 19.
- Background: PubMed 27608677Kampmeijer R, Pavlova M, Tambor M, Golinowska S, Groot W. The use of e-health and m-health tools in health promotion and primary prevention among older adults: a systematic literature review. BMC Health Serv Res. 2016 Sep 5;16 Suppl 5(Suppl 5):290. doi: 10.1186/s12913-016-1522-3.
- Background: PubMed 28507010Wang Y, Xue H, Huang Y, Huang L, Zhang D. A Systematic Review of Application and Effectiveness of mHealth Interventions for Obesity and Diabetes Treatment and Self-Management. Adv Nutr. 2017 May 15;8(3):449-462. doi: 10.3945/an.116.014100. Print 2017 May.
- Background: PubMed 26096563Chen SY, Stem M, Schweitzer MA, Magnuson TH, Lidor AO. Assessment of postdischarge complications after bariatric surgery: A National Surgical Quality Improvement Program analysis. Surgery. 2015 Sep;158(3):777-86. doi: 10.1016/j.surg.2015.04.028. Epub 2015 Jun 19.
- Background: PubMed 25829315Montravers P, Augustin P, Zappella N, Dufour G, Arapis K, Chosidow D, Fournier P, Ribeiro-Parienti L, Marmuse JP, Desmard M. Diagnosis and management of the postoperative surgical and medical complications of bariatric surgery. Anaesth Crit Care Pain Med. 2015 Feb;34(1):45-52. doi: 10.1016/j.accpm.2014.06.002. Epub 2015 Mar 5.
- 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.
Michel Vix, MD principal investigator
Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring evaluation by connected devices: Wristband activity tracker "Garmin Vivosmart® 3", "Fora® Scale 550", "Terraillon® Tensioscreen", Pulse oximeter "Nonin® 3230", thermometer "Fora® IR20b" in people with Bariatric Surgery Candidate, run by IHU Strasbourg at 1 site in France.
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 11 inclusion and 13 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 10 Feb 2021. 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 France. 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?
Reliability of a remote monitoring system during treatment for bariatric surgery evaluated in days between two failures (time frame: From the inclusion to 6 months after the surgery). 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 NCT03834181, 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 10 Feb 2021.